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Sp02 9-pin D-sub Adapter cbl 1.1m(8-pin)

by Philips Medizin Systeme Böblingen GmbH

Ref 989803105691

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM562T9 Basic UDI-DI 00884838011939UDI-DIDate28 Aug 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838011939 UDI-DI Date23 Nov 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

2 recalls · FDA

    • Terminated Z-2053-2020 FDA Class II initiated 13 Apr 2020 on shared 510(k) K001725

    The rotary therapy selector switch may fail, resulting in unexpected device behavior including: 1) The device may not turn on; 2) The device may not perform the selected function;3) The device may deliver a shock with an energy level different than the setting selected by the user. In any of these scenarios, appropriate therapy delivery may be delayed.

    • Terminated Z-0343-03 FDA Unclassified (pre-2012) initiated 25 Nov 2002 on shared 510(k) K001725

    Defective energy switch may cause Defibrillator to turn off or charge to a different energy level than was selected.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Sp02 9-pin D-sub Adapter cbl 1.1m(8-pin) EUDAMED
SpO2 Cable GUDID
Generic Name
Electrical-only medical device connection cable, reusable
Device Name
SPO2 Adapters and Cables
Model / Ref / Catalog
989803105691
Primary DI / UDI-DI
00884838011939
Basic UDI-DI
0884838BM562T9
FDA Product Code
DQA
EMDN Code
Z12030280 Vital signs monitoring instruments - hardware accessories
GMDN Term
Electrical-only medical device connection cable, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.2700
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006026

Related devices

Category: Electrical-only medical device connection cable, reusable

Other devices from Philips Medizin Systeme Böblingen GmbH

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No