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Invos PMAC71RSC

by Covidien LP

Ref PMAC71RSC

Invos PMAC71RSC is a device classified as Class I in the EU and Class II in the US made by Covidien LP, registered in EUDAMED on 17 Aug 2026 (Basic UDI-DI 0763000B00001306U), cleared under FDA 510(k) K182868 on 8 Jan 2019 and listed in FDA GUDID since 31 Jul 2019 (UDI-DI 10884521780125), active as of 24 Oct 2026. One FDA recall is 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K182868

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001306U Basic UDI-DI 10884521780125UDI-DIDate17 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10884521780125 UDI-DI Date31 Jul 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK182868 Date8 Jan 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001306U registered 17 Aug 2026 Active
  • FDA 510(k) K182868 decided 8 Jan 2019 Active
  • FDA GUDID UDI-DI 10884521780125 listed 31 Jul 2019 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1732-2024 FDA Class II initiated 9 Jan 2024

    manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel

Timeline

4 dated events

  1. Cleared FDA 510(k) K182868
  2. Listed FDA GUDID 10884521780125
  3. Recall initiated FDA recalls Z-1732-2024
  4. Registered EUDAMED 0763000B00001306U

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  • Withdrawn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
Invos
Generic name
Electrical-only medical device connection cable, reusable
Device name
Invos PM7100 Re-Usable Sensor Cable
Model / reference
PMAC71RSC
Primary DI / UDI-DI
10884521780125
Basic UDI-DI
0763000B00001306U
510(k) Number
FDA product code
MUD
EMDN code
Z1203020407 Subcutaneous oximeters
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.2700
EU registration type
Standard device
EU market of registration
Netherlands
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

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: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K182868)

and 8 more cleared under K182868

Similar devices in this category

Other devices filed under GASEOUS EXCHANGE MONITORING INSTRUMENTS.

Other devices from Covidien LP

  • LigaSure MRASILF19

    Class II

  • Shiley 110860

    Class II

  • Shiley 110865

    Class II

  • Shiley 110870

    Class II

See all devices from Covidien LP →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)