Skip to content

Solventum™ ActiV.A.C.™ M8275058/5 M8275058/10

by Kci USA, Inc.

Ref M8275058/10 M8275058/5

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00197998301148 UDI-DI Date23 Jul 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number084955408401010000000086B Basic UDI-DI 00197998301148UDI-DIDate17 Jun 2026RegisteredStatusActive

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.

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  • Withdrawn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
Solventum™ ActiV.A.C.™
Generic Name
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Name
ActiV.A.C.™ Canister with Gel 300 mL
Model / Ref / Catalog
M8275058/10 M8275058/5 EUDAMED
M8275058/5 M8275058/10 GUDID
Primary DI / UDI-DI
00197998301148
Basic UDI-DI
084955408401010000000086B
FDA Product Code
OMP
EMDN Code
A0699 Drainage and fluid collection devices - other
GMDN Term
Negative-pressure wound therapy system foam dressing, non-antimicrobial
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
878.4780
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M8275058/10 M8275058/5
GUDID
M8275058/5 M8275058/10
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Kci USA, Inc.

See all devices from Kci USA, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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