DOC-20000 EU MDR BPC Dec of Conf Rev 3
DOC-20000 EU MDR BPC Dec of Conf Rev 3
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Blood Pressure Cuffs
Product Name:
Intended Purpose:
Blood Pressure Cuffs are used in conjunction with non invasive blood pressure monitors to screen for hypertension and monitoring of blood pressure,
Model Number or Designator:
See attached
DOC-20000 12-Sept-2022
Control Designator: Device Classification:
Class 1, Rule 1, according to the European Medical Device Regulation 2017/745, Annex VIII Route of conformity is according to (EU) MDR Annex IX Quality Management System Z12030285, Vital Signs Monitoring Instruments - Consumables
Conformity Route:
EMDN Nomenclature code (EMDN):
34978 , Cuff, Blood Pressure, Reusable 37326 , Cuff, Blood Pressure, Single-Use 11073 , Cuffs, Blood Pressure
Global Medical Device Nomenclature Code (GMDN):
Universal Medical Device Nomenclature System (UMDNS)
Product Options/Accessories: N/A The Manufacturer is certified by the Notified Body listed below to ISO 13485:2016 & EN ISO 13485:2016 Quality Management System. Certificate Number: MD 608599. Notified Body: BSI Group Inc., Notified Body CE 2797 Say Building John M. Keynesplein 9 1066 EP Amsterdam Netherlands www.bsigroup.com Authorized EU Representative: MT Promedt Consulting GmbH Ernst-Heckel-Straße 7 66386 St. Ingbert Germany Revision: 3
Date of Issue: 12-Sept-2022
Authorized Signature and function
Place of Issue: Regulatory Office, SunMed Grand Rapids, Michigan, 49544 USA
Printed Name: Rob Yamashita, VP Regulatory
This declaration of conformity is issued under the sole responsibility of Salter Labs. We hereby declare that the medical device(s) specified above meet the provision of the Regulation (EU) MDR 2017/745 for medical devices. All technical documentation is retained at the premises of the manufacturer/technical documentation location.
Doc # FRM-10001 Rev 3
Page 1 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Blood Pressure Cuffs
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411940446 10607411940443 00607411940453 10607411940450 00607411940460 10607411940467 00607411940477 10607411940474 00607411923760 10607411923767 00607411911828 10607411911825 00607411920295 10607411920292 00607411917004 10607411917001 00607411920301 10607411920308 00607411917011 10607411917018 00607411922299 10607411922296 00607411923791 10607411923798 00607411923814 10607411923811 00607411913464 10607411913461 00607411911835 10607411911832 00607411920332 10607411920339 00607411917028 10607411917025
AP-02009-1-1 AP-02009-1-50 AP-0200A-1 AP-0200A-50 AP-0200C-1 AP-0200C-1-50 AP-0200D-1-1 AP-0200D-1-50 ZCC4001D-1 ZCC4001D-10 ZCC4001HP-1 ZCC4001HP-10 ZCC4001L-1 ZCC4001L-10 ZCC4001P-1 ZCC4001P-10 ZCC4001X-1 ZCC4001X-10 ZCC4002MQF-1 ZCC4002MQF-10 ZCC4002MQMF-1 ZCC4002MQMF-10 ZCC4002X-1 ZCC4002X-10 ZCC4012L-1 ZCC4012L-10 ZCC4101D-1 ZCC4101D-10 ZCC4101HP-1 ZCC4101HP-10 ZCC4101L-1 ZCC4101L-10 ZCC4101MQF-1 ZCC4101MQF-10
NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-5cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube
Doc # FRM-10001 Rev 3
Page 2 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411913471 10607411913478 00607411915307 10607411915304 00607411920349 10607411920346 00607411912092 10607411912099 00607411917035 10607411917032 00607411920356 10607411920353 00607411922305 10607411922302 00607411923609 10607411923606 00607411920363 10607411920360 00607411923616 10607411923613 00607411923951 10607411923958 00607411920387 10607411920384 00607411913488 10607411913485 00607411911842 10607411911849 00607411918926 10607411918923 00607411917059 10607411917056 00607411918933 10607411918930 00607411915314 10607411915311
ZCC4101MQM-1 ZCC4101MQM-10
ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube
ZCC4101P-1 ZCC4101P-10 ZCC4101X-1 ZCC4101X-10 ZCC4102D-1 ZCC4102D-10
ZCC4102MQF-1 ZCC4102MQF-10 ZCC4102MQMF-1 ZCC4102MQMF-10
ZCC4102X-1 ZCC4102X-10
ZCC4121MQF-1 ZCC4121MQF-10
ZCC4121P-1 ZCC4121P-10
ZCC4122MQF-1 ZCC4122MQF-10 ZCC4122X-1 ZCC4122X-10 ZCC4201D-1 ZCC4201D-10 ZCC4201F-1 ZCC4201F-10 ZCC4201HP-1 ZCC4201HP-10 ZCC4201L-1 ZCC4201L-10 ZCC4201MQF-1 ZCC4201MQF-10 ZCC4201MQM-1 ZCC4201MQM-10
ZCC4201P-1 ZCC4201P-10
Doc # FRM-10001 Rev 3
Page 3 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411917066 10607411917063 00607411912108 10607411912105 00607411915444 10607411915441 00607411915451 10607411915458 00607411915468 10607411915465 00607411920400 10607411920407 00607411920417 10607411920414 00607411925269 10607411925266 00607411911859 10607411911856 00607411917073 10607411917070 00607411920424 10607411920421 00607411917097 10607411917094 00607411920431 10607411920438 00607411925320 10607411925327 00607411920448 10607411920445 00607411915321 10607411915328 00607411912122 10607411912129 00607411913082 10607411913089
ZCC4201X-1 ZCC4201X-10 ZCC4202D-1 ZCC4202D-10
ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube
ZCC4202MQF-1 ZCC4202MQF-10 ZCC4202MQMF-1 ZCC4202MQMF-10 ZCC4202X-1 ZCC4202X-10 ZCC4212HP-1 ZCC4212HP-10 ZCC4212X-1 ZCC4212X-10 ZCC4221F-1 ZCC4221F-10 ZCC4221HP-1 ZCC4221HP-10 ZCC4221MQF-1 ZCC4221MQF-10 ZCC4222MQF-1 ZCC4222MQF-10 ZCC4222MQMF-1 ZCC4222MQMF-10 ZCC4222X-1 ZCC4222X-10 ZCC4301D-1 ZCC4301D-10 ZCC4301HP-1 ZCC4301HP-10 ZCC4301L-1 ZCC4301L-10 ZCC4301MQF-1 ZCC4301MQF-10 ZCC4221P-1 ZCC4221P-10
Doc # FRM-10001 Rev 3
Page 4 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411918940 10607411918947 00607411913099 10607411913096 00607411912115 10607411912112 00607411913105 10607411913102 00607411913105 10607411913102 00607411913112 10607411913119 00607411918957 10607411918954 00607411915475 10607411915472 00607411913129 10607411913126 00607411913136 10607411913133 00607411913143 10607411913140 00607411920493 10607411920490 00607411915482 10607411915489 00607411923739 10607411923736 00607411920509 10607411923743
ZCC4301MQM-1 ZCC4301MQM-10
ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Double Tube ComfortCheck Disposable Blood Pressure Cuff Child (11-22cm) - Double Tube
ZCC4301P-1 ZCC4301P-10 ZCC4302D-1 ZCC4302D-10
ZCC4302MQF-1 ZCC4302MQF-10 ZCC4302MQMF-1 ZCC4302MQMF-10 ZCC4302X-1 ZCC4302X-10 ZCC4401D-1 ZCC4401D-10 ZCC4401HP-1 ZCC4401HP-10 ZCC4401L-1 ZCC4401L-10 ZCC4401MQF-1 ZCC4401MQF-10
ZCC4401P-1 ZCC4401P-10 ZCC4401X-1 ZCC4401X-10 ZCC4402D-1 ZCC4402D-10
ZCC4402MQMF-1 ZCC4402MQMF-10
ZCC4402X-1 ZCC4402X-10
Doc # FRM-10001 Rev 3
Page 5 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411940484 10607411940481 00607411940491 10607411940498 00607411940507 10607411940504 00607411940514 10607411940511 00607411940521 10607411940528 00607411940538 10607411940535 00607411911866 10607411911863 00607411920516 10607411920513 00607411920530 10607411920537 00607411920547 10607411920544 00607411920554 10607411920551 00607411920578 10607411920575 00607411922169 10607411922166 00607411915338 10607411915335 00607411915499 10607411915496 00607411920585 10607411920582 00607411913167 10607411913164 00607411915505 10607411915502 00607411915512 10607411915519 00607411920592 10607411920599
DXVC4002X-1 DXVC4002X-50 DXVC4902X DXVC4902X-50 DXVCC4102X DXVCC4102X-50 DXVCC4202X DXVCC4202X-50 DXVCC4302X DXVCC4302X-50 DXVCC4402X DXVCC4402X-50 ZDC4001HP-1 ZDC4001HP-5 ZDC4002X-1 ZDC4002X-5 ZDC4101D-1 ZDC4101D-5 ZDC4101F-1 ZDC4101F-5 ZDC4101HP-1 ZDC4101HP-5 ZDC4101P-1 ZDC4101P-5 ZDC4101X-1 ZDC4101X-5 ZDC4102D-1 ZDC4102D-5 ZDC4102MQF-1 ZDC4102MQF ZDC4102MQMF-1 ZDC4102MQMF-5 ZDC4001P-1 ZDC4001P-5 ZDC4002D-1 ZDC4002D-5 ZDC4002MQMF-1 ZDC4002MQMF-5
VitalCheck Reusable Blood Pressure Cuff Thigh (45-52cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Infant (9-15cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-4cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (27-35cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Small Adult (20.5-28.5cm) - Double Tube DIXTAL CHILD VITALCHECK, 2T NO CONNECTOR DuraCheck Reusable Blood Pressure Cuff Thigh (39-55cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Thigh (39-55cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Thigh (39-55cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Thigh (39-55cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Thigh (39-55cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube
ZDC4102X-1 ZDC4102X-5
Doc # FRM-10001 Rev 3
Page 6 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411925658 10607411925655 00607411915529 10607411915526 00607411926952 10607411926959 00607411920608 10607411920605 00607411921919 10607411921916 00607411915536 10607411915533 00607411915543 10607411915540 00607411911873 10607411911870 00607411913174 10607411913171 00607411915345 10607411915342 00607411927027 10607411927024 00607411915550 10607411915557 00607411915567 10607411915564 00607411915574 10607411915571 00607411921933 10607411921930 00607411918919 10607411918916 00607411927089 10607411927086 00607411927102 10607411927109 00607411911880 10607411911887 00607411927126 10607411927123 00607411913198 10607411913195 00607411915581 10607411915588
ZDC4112P-1 ZDC4112P-5 ZDC4121HP-1 ZDC4121HP-5 ZDC4121MQF-1 ZDC4121MQF ZDC4121P-1 ZDC4121P-5 ZDC4122X-1 ZDC4122X-5 ZDC4201D-1 ZDC4201D-5 ZDC4201F-1 ZDC4201F-5 ZDC4201HP-1 ZDC4201HP-5 ZDC4201MQF-1 ZDC4201MQF-5 ZDC4202MQF-1 ZDC4202MQF-5 ZDC4202MQMF-1 ZDC4202MQMF-5 ZDC4202X-1 ZDC4202X-5 ZDC4212HP-1 ZDC4212HP-5 ZDC4212L-1 ZDC4212L-5 ZDC4221F-1 ZDC4221F-5 ZDC4221HP-1 ZDC4221HP-5 ZDC4221MQF-1 ZDC4221MQF-5 ZDC4201P-1 ZDC4201P-5 ZDC4201X-1 ZDC4201X-5 ZDC4202D-1 ZDC4202D-5
DuraCheck Reusable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Large Adult Long (33-41cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube
ZDC4221P-1 ZDC4221P-5 ZDC4221X-1 ZDC4221X-5
Doc # FRM-10001 Rev 3
Page 7 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411921988 10607411921985 00607411913204 10607411913201 00607411911552 10607411911559 00607411921995 10607411921992 00607411911897 10607411911894 00607411950988 10607411950985 00607411913211 10607411913218 00607411922015 10607411922012 00607411927232 10607411927239 00607411913228 10607411913225 00607411922022 10607411922029 00607411927287 10607411927284 00607411922039 10607411922036 00607411911569 10607411911566 00607411911576 10607411911573 00607411913235 10607411913232 00607411913242 10607411913249 006074119132598 1060741191325661 00607411922046 10607411922043 00607411928673 10607411928670 00607411928697 10607411928694 00607411913266 10607411913263
ZDC4222D-1 ZDC4222D-5
DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm)-Single Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Sm. Adult (16-28cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Child (11-22cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Infant (8-15cm) - Single Tube
ZDC4222MQF-1 ZDC4222MQF-5 ZDC4222MQMF-1 ZDC4222MQMF-5 ZDC4222X-1 ZDC4222X-5 ZDC4301HP-1 ZDC4301HP-5 ZDC4301MQF-1 ZDC4301MQF-5
ZDC4301P-1 ZDC4301P-5 ZDC4301X-1 ZDC4301X-5 ZDC4302D-1 ZDC4302D-5
ZDC4302MQF-1 ZDC4302MQF-5 ZDC4302MQMF-1 ZDC4302MQMF-5 ZDC4302X-1 ZDC4302X-5 ZDC4401D-1 ZDC4401D-5 ZDC4401HP-1 ZDC4401HP-5 ZDC4401P-1 ZDC4401P-5 ZDC4401X-1 ZDC4401X-5 ZDC4402D-1 ZDC4402D-5 ZDC4402MQF-1 ZDC4402MQF-5 ZDC4402MQMF-1 ZDC4402MQMF-5
ZDC4402X-1 ZDC4402X-5 ZDC4412L-1 ZDC4412L-5 ZDC4901HP-1 ZDC4901HP-5
Doc # FRM-10001 Rev 3
Page 8 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411913273 10607411913270 00607411913273 10607411911580 00607411922077 10607411922074 00607411928758 10607411928755 00607411911996 10607411911993 00607411913297 10607411913294 00607411911934 10607411911931 00607411913303 10607411913300 00607411961083 10607411961080 00607411913310 10607411913317 00607411934070 10607411934077 00607411913327 10607411913324 00607411913334 10607411913331 00607411911699 10607411911696 00607411922176 10607411922173 00607411911705 10607411911702 00607411928796 10607411928793 00607411911408 10607411911405
ZDC4901P-1 ZDC4901P-5 ZDC4901X-1 ZDC4901X-5 ZDC4902X-1 ZDC4902X-5 ZDC4912L-1 ZDC4912L-5 ZNC4501F-1 ZNC4501F-10 ZNC4501HP-1 ZNC4501HP-10 ZNC4501L-1 ZNC4501L-10 ZNC4501MQF-1 ZNC4501MQF-10 ZNC4502MQF-1 ZNC4502MQF-10 ZNC4601F-1 ZNC4601F-10 ZNC4601HP-1 ZNC4601HP-10 ZNC4601L-1 ZNC4601L-10 ZNC4601MQF-1 ZNC4601MQF-10 ZNC4502D-1 ZNC4502D-10 ZNC4502L-1 ZNC4502L-10
DuraCheck Reusable Blood Pressure Cuff Infant (8-15cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Infant (8-15cm) - Single Tube DuraCheck Reusable Blood Pressure Cuff Infant (8-15cm) - Double Tube DuraCheck Reusable Blood Pressure Cuff Infant (8-15cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal Size (3-6cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube
ZNC4602L-1 ZNC4602L-10
ZNC4602MQF-1 ZNC4602MQF-10
ZNC4701F-1 ZNC4701F-10
Doc # FRM-10001 Rev 3
Page 9 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411913341 10607411913348 00607411911941 10607411911948 00607411913358 10607411913355 00607411916489 10607411916486 00647011911415 10607411911412 00607411928802 10607411928809 00607411911422 10607411911429 00607411913365 10607411913362 00607411915352 10607411915359 00607411913372 10607411913379 00607411915277 10607411915274 00607411935589 10607411935586 00607411911439 10607411911436 00607411918742 10607411918749 00607411918759 10607411918756 00607411918766 10607411918763 00607411916526 10607411916523 00607411911446 10607411911443
ZNC4701HP-1 ZNC4701HP-10 ZNC4701L-1 ZNC4701L-10 ZNC4701MQF-1 ZNC4701MQF-10 ZNC4701SML-1 ZNC4701SML-10 ZNC4702MQF-1 ZNC4702MQF-10 ZNC4801F-1 ZNC4801F-10 ZNC4801HP-1 ZNC4801HP-10 ZNC4801L-1 ZNC4801L-10 ZNC4801MQF-1 ZNC4801MQF-10 ZNC4802MQF-1 ZNC4802MQF-10 ZNC4901F-1 ZNC4901F-10 ZNC4901HP-1 ZNC4901HP-10 ZNC4901L-1 ZNC4901L-10 ZNC4901MQF-1 ZNC4901MQF-10 ZNC4702L-1 ZNC4702L-10 ZNC4802L-1 ZNC4802L-10
NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal Size (7-13cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Double Tube
ZNC4902D-1 ZNC4902D-10 ZNC4902L-1 ZNC4902L-10
Doc # FRM-10001 Rev 3
Page 10 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411935688 10607411935685 00607411916533 10607411916530 00607411911958 10607411911955 00607411930362 10607411930369 00607411911453 10607411911450 00607411915284 10607411915281 00607411916540 10607411916547 00607411911460 10607411911467 00607411911477 10607411911474 00607411915291 10607411915298 00607411937118 10607411937115 00607411939105 10607411939102 00607411916557 10607411916554 00607411911484 10607411911481 00607411911491 10607411911498 00607411911965 10607411911962 00607411961335 10607411961332 00607411911507 10607411911504
ZNC4902MQF-1 ZNC4902MQF-10 ZNCV4501HP-1 ZNCV4501HP-10 ZNCV4501L-1 ZNCV4501L-10 ZNCV4502HP-1 ZNCV4502HP-10 ZNCV4601HP-1 ZNCV4601HP-10 ZNCV4601L-1 ZNCV4601L-10 ZNCV4602HP-1 ZNCV4602HP-10 ZNCV4602L-1 ZNCV4602L-10 ZNCV4701HP-1 ZNCV4701HP-10 ZNCV4701L-1 ZNCV4701L-10 ZNCV4701MQF-1 ZNCV4701MQF-10 ZNCV4701MQM-1 ZNCV4701MQM-10 ZNCV4702HP-1 ZNCV4702HP-10 ZNCV4702L-1 ZNCV4702L-10 ZNCV4801HP-1 ZNCV4801HP-10 ZNCV4801L-1 ZNCV4801L-10 ZNCV4802HP-1 ZNCV4802HP-10 ZNCV4802L-1 ZNCV4802L-10
NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (3-6cm) - Single Tube NeoCheck Disposable blood Pressure Cuff Neonatal Size #1 (3-6cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (4-8cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal Size (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal Size (6-11cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (6-11cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (7-13cm) - Double Tube
Doc # FRM-10001 Rev 3
Page 11 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411916564 10607411916561 00607411911972 10607411911979 00607411928826 10607411928823 00607411911514 10607411911511 00607411916595 10607411916592 00607411920226 10607411920223 00607411918797 10607411918794 00607411928895 10607411928892 00607411920233 10607411920230 00607411920233 10607411920230 00607411912146 10607411912143 00607411911538 10607411911535 00607411928949 10607411928946 00607411938740 10607411938747 00607411938832 10607411938839 00607411913747 10607411913744 00607411913730 10607411913737 00607411913723 10607411913720
ZNCV4901HP-1 ZNCV4901HP-10 ZNCV4901L-1 ZNCV4901L-10 ZNCV4902HP-1 ZNCV4902HP-10 ZNCV4902L-1 ZNCV4902L-10 ZSC4001HP-1 ZSC4001HP-10 ZSC4001L-1 ZSC4001L-10 ZSC4001P-1 ZSC4001P-10 ZSC4002X-1 ZSC4002X-10 ZSC4101HP-1 ZSC4101HP-10 ZSC4101MQF-1 ZSC4101MQF-10 ZSC4102X-1 ZXC4102X-10 ZSC4121HP-1 ZSC4121HP-10 ZSC4122X-1 ZSC4122X-10 ZSC4201HP-1 ZSC4201HP-10 ZSC4201L-1 ZSC4201L-10 ZSC4201MQF-1 ZSC4201MQF-10 ZSC4101P-1 ZSC4101P-10 ZSC4102MQF-1 ZSC4102MQF-10
NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Single Tube NeoCheck Disposable Blood Pressure Cuff Neonatal Size #5 (8-15cm)-Double Tube NeoCheck Disposable Blood Pressure Cuff Neonatal (8-15cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Thigh (39-55cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Large Adult (33-41cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Large Adult Long (33-41cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube
Doc # FRM-10001 Rev 3
Page 12 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411912153 10607411912150 00607411916632 10607411916639 00607411911545 10607411911542 00607411916649 10607411916646 00607411938955 10607411938952 00607411911989 10607411911986 00607411920240 10607411920247 00607411920257 10607411920254 00607411912177 10607411912174 00607411929021 10607411929028 00607411916656 10607411916653 00607411929038 10607411929035 00607411916670 10607411916677 00607411912207 10607411912204 00607411916687 10607411916684 00607411912214 10607411912211 00607411912221 10607411912228 00607411930331 10607411930338
ZSC4201P-1 ZSC4201P-10 ZSC4202X-1 ZSC4202X-10 ZSC4212P-1 ZSC4212P-10 ZSC4221HP-1 ZSC4221HP-10 ZSC4222X-1 ZSC4222X-10 ZSC4301HP-1 ZSC4301HP-10 ZSC4301L-1 ZSC4301L-10 ZSC4301MQF-1 ZSC4301MQF-10 ZSC4302MQF-1 ZSC4302MQF-10 ZSC4302X-1 ZXC4302X-10 ZSC4401F-1 ZSC4401F-10 ZSC4401HP-1 ZSC4401HP-10 ZSC4401L-1 ZSC4401L-10 ZSC4401MQF-1 ZSC4401MQF-10 ZSC4301P-1 ZSC4301P-10 ZSC4301X-1 ZSC4301X-10
StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Adult (26-33cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Adult Long (26-33cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Small Adult (16-28cm) - Double Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Single Tube StatCheck Disposable Blood Pressure Cuff Child (11-22cm) - Double Tube
ZSC4401P-1 ZSC4401P-10 ZSC4402X-1 ZSC4402X-10
Doc # FRM-10001 Rev 3
Page 13 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411913518 10607411913515 00607411928772 10607411928779 00607411932083 10607411932080 00607411930546 10607411930543 00607411913525 10607411913522 00607411913532 10607411913539 00607411915123 10607411915120 00607411930621 10607411930628 00607411931994 10607411931991 00607411913549 10607411913546 00607411932014 10607411932011 00607411940408 10607411940408 00607411916458 10607411916455 00607411916458 10607411916455 00607411930447 10607411930444 00607411913563 10607411913560 00607411913570 10607411913577 00607411932328 10607411932325 00607411913587 10607411913584 00607411915079 10607411915076 00607411915086 10607411915083 00607411913600 10607411913607
ZVC4001HP-1 ZVC4001HP-5 ZVC4001X-1 ZVC4001X-5 ZVC4002D-1 ZVC4002D-5 ZVC4012HP-1 ZVC4012HP-5 ZVC4901HP-1 ZVC4901HP-5 ZVC4901MQF-1 ZVC4901MQF ZVC4901P-1 ZVC4901P-5 ZVC4901X-1 ZVC4901X-5 ZVCC4101F-1 ZVCC4101F-5 ZVCC4101HP -1 ZVCC4101HP-5 ZVCC4101X-1 ZVCC4101X-5 ZVCC4102D-1 ZVCC4102D-5 ZVCC4112HP-1 ZVCC4112HP-5 ZVCC4121HP-1 ZVCC4121HP-5 ZVCC4121X-1 ZVCC4121X-5 ZVCC4201HP-1 ZVCC4201HP-5 ZVCC4201P-1 ZVCC4201P-5 ZVCC4201X-1 ZVCC4201X-5 ZVCC4202D-1 ZVCC4202D-5
VitalCheck Reusable Blood Pressure Cuff Thigh (42-52cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Thigh (42-52cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Thigh (42-52cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Thigh (42-52cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Infant (9-15cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Infant (9-15cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Infant (9-15cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Infant (9-15cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-44cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-44cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-44cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-44cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Large Adult (34-44cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Large Adult Long (34-44cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Large Adult Long (34-44cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Adult Long (27-35cm) - Single Tube
ZVCC4202MQMF-1 ZVCC4202MQMF-5
ZVCC4212HP-1 ZVCC4212HP-5 ZVCC4221HP-1 ZVCC4221HP-5
Doc # FRM-10001 Rev 3
Page 14 of 15
Salter Labs 30 Spur Drive El Paso, TX 79906 USA
DECLARATION OF CONFORMITY
DOC-20000
SRN: US-MF-000007934
Blood Pressure Cuffs
Basic UD I: 006074TF1029_BPCuffs9K
Each Model Number -1 Model Number with Case Qty -XX
UDIs
Blood Pressure Cuff Description
00607411930454 10607411930451 00607411913617 10607411913614 00607411933790 10607411933797 00607411961069 10607411961066 00607411913655 10607411913652 00607411913662 10607411913669 00607411933936 10607411933933
ZVCC4221X-1 ZVCC4221X-5 ZVCC4301HP-1 ZVCC4301HP-5 ZVCC4301X-1 ZVCC4301X-5 ZVCC4312HP-1 ZVCC4312HP-5 ZVCC4401HP-1 ZVCC4401HP-5 ZVCC4401MQF-1 ZVCC4401MQF-5
VitalCheck Reusable Blood Pressure Cuff Adult (27-35cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Small Adult (20.5-28.5cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Small Adult (20.5-28.5cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Small Adult (20.5-28.5cm) - Double Tube VitalCheck Reusable Blood Pressure Cuff Child (14-21.5cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Child (14-21.5cm) - Single Tube VitalCheck Reusable Blood Pressure Cuff Child (14-21.5cm) - Single Tube
ZVCC4401X-1 ZVCC4401X-5
Doc # FRM-10001 Rev 3
Page 15 of 15
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