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B.braun 7102771

by B.Braun Avitum AG

Ref 7102771

B.braun 7102771 is a device classified as Class I in the EU and Class II in the US made by B.Braun Avitum AG, registered in EUDAMED on 6 Feb 2025 (Basic UDI-DI 4039239000000210Z9), cleared under FDA 510(k) K083460 on 18 Feb 2010 (1 earlier submission) and listed in FDA GUDID since 9 Aug 2015 (UDI-DI 04039239040859), active as of 23 Oct 2026. 8 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

8 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K083460

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4039239000000210Z9 Basic UDI-DI 04039239040859UDI-DIDate6 Feb 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04039239040859 UDI-DI Date9 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK083460 Date18 Feb 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 4039239000000210Z9 registered 6 Feb 2025 Active
  • FDA 510(k) K083460 decided 18 Feb 2010 Active· +1 more in the status table
  • FDA GUDID UDI-DI 04039239040859 listed 9 Aug 2015 Listed

Recalls

8 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0872-2022 FDA Class II initiated 28 Jan 2022
    • Terminated Z-0873-2022 FDA Class II initiated 28 Jan 2022

    Firm learned of the potential for cracks to form in the conductivity sensors during use, which may lead to a leak in the dialysate circuit. This could result in excessive ultrafiltration or insufficient ultrafiltration depending on whether the dialysis machine is equipped with a Dialysis Fluid filter.

  • 6 recalls, same reason

    • Terminated Z-1532-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1535-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1531-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1536-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1533-2016 FDA Class I initiated 1 Apr 2016
    • Terminated Z-1534-2016 FDA Class I initiated 1 Apr 2016

    Potential leakage of conductivity sensors of the Dialog Dialysis machines.

Timeline

12 dated events

  1. Listed FDA GUDID 04039239040859
  2. Recall initiated FDA recalls Z-1532-2016
  3. Recall initiated FDA recalls Z-1535-2016
  4. Recall initiated FDA recalls Z-1531-2016
  5. Recall initiated FDA recalls Z-1536-2016
  6. Recall initiated FDA recalls Z-1533-2016
  7. Recall initiated FDA recalls Z-1534-2016
  8. Recall initiated FDA recalls Z-0872-2022
  9. Recall initiated FDA recalls Z-0873-2022
  10. Registered EUDAMED 4039239000000210Z9

2 earlier events are in the sections above.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Abpm Cuff (M) EUDAMED
B.braun GUDID
Generic name
Blood pressure cuff, reusable
Device name
ABPM Cuff
Model / Ref / Catalog
7102771
Primary DI / UDI-DI
04039239040859
Basic UDI-DI
4039239000000210Z9
Direct marketing DI
04039239040859
510(k) Number
FDA product code
KDI
EMDN code
Z1203020302 Non–invasive blood pressure monitoring instruments
GMDN term
Blood pressure cuff, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.5860
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Blood pressure cuff, reusable

Cleared under the same submission (K083460)

and 8 more cleared under K083460

Cleared under the same submission (K963440)

and 8 more cleared under K963440

Similar devices in this category

Other devices filed under NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS.

Other devices from B.Braun Avitum AG

See all devices from B.Braun Avitum AG →

Properties

  • Prescription use
  • Lot / batch number
Other properties (23, all answered No)