FDA.reportPublic FDA data

KCI Manufacturing

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30068083923006808392KCI Manufacturing1N2026-01-01IDA Business andTechnology Park Dublin Road Athlone - Co. Westmeath IE --

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3441741483134010K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)OMP2024-05-23
3441741580745206K223263Prevena Plus 125 Therapy UnitQFC2023-02-13
3441741819355247K2228593M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG)OMP2023-03-23
3441741817512996K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing KitOMP2023-03-23
3441741799147345K220660Prevena Restor Adapti-Form DressingOMP2022-07-01
3441741308290063K220560Dermatac DrapeOMP2022-07-14
3441741891173139K212320Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pacOMP2021-09-28
3441742003361648K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2021-10-27
3441741557934940K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemOMP2020-07-08
3441741087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
3441741172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
3441741141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
3441741586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
3441741497184851K153199Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-PackOMP2016-02-29
3441741556321095K151710SNaP Wound Care SystemOKO2015-11-19
3441742041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
3441741513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
3441741687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
3441741659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
3441741659207151K100657V.A.C. ULTA NEGATIVE PRESSURE WOUND THERAPY SYSTEM (V.A.C. ULTA THERAPY SYSTEM) MODEL V.A.C. ULTA THERAPY UNIT MODEL UOMP2010-09-17

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMP182024-05-23
QFC12023-02-13
OKO12015-11-19