FDA.reportPublic FDA data

KCI USA, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30051782453005178245KCI USA, INC.1Y2026-01-016203 FARINON DR. SAN ANTONIO TX US 78249
30098970213009897021KCI USA, INC.1Y2026-01-0112930 IH 10 West San Antonio TX US 78249
30051782453005178245KCI USA, INC.1N2020-04-256203 FARINON DR. SAN ANTONIO TX US 78249
30098970213009897021KCI USA, INC.1N2020-04-2512930 IH 10 West San Antonio TX US 78249

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00197998276507Solventum™ V.A.C.® Granufoam™ - V.A.C.® Granufoam™ Dressing Kit, X-Large+1(800)228-3957regulatoryrequests@solventum.com
00197998300912Solventum™ V.A.C.® Granufoam™ - V.A.C.® Granufoam™ Dressing Kit, Large+1(800)228-3957regulatoryrequests@solventum.com
00197998301148Solventum™ ActiV.A.C.™ - Solventum™ ActiV.A.C.™ SensaT.R.A.C.™ Canister with Gel, 300ml+1(800)228-3957regulatoryrequests@solventum.com
00197998301162Solventum™ ActiV.A.C.™ - Solventum™ ActiV.A.C.™ SensaT.R.A.C.™ Canister with Gel, 300ml+1(800)228-3957regulatoryrequests@solventum.com
00197998301209Solventum™ V.A.C.® Granufoam™ - V.A.C.® Granufoam™ Dressing Kit, Large+1(800)228-3957regulatoryrequests@solventum.com
00197998301285Solventum™ V.A.C.® Granufoam™ - V.A.C.® Granufoam™ Dressing Kit, Medium+1(800)228-3957regulatoryrequests@solventum.com
00197998301360Solventum™ V.A.C.® Granufoam™ - V.A.C.® Granufoam™ Dressing Kit, Small+1(800)228-3957regulatoryrequests@solventum.com
00197998303906Solventum™ ActiV.A.C.™ - Solventum™ ActiV.A.C.™ SensaT.R.A.C.™ Canister with Gel, 300ml+1(800)228-3957regulatoryrequests@solventum.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2347061503772465K982597FIBRCOL PLUS COLLAGEN WOUND DRESSING WITH ALGINATEKGN1998-08-20
3441751483134010K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)OMP2024-05-23
3441721483134010K2411343M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10)OMP2024-05-23
3441751580745206K223263Prevena Plus 125 Therapy UnitQFC2023-02-13
3441721580745206K223263Prevena Plus 125 Therapy UnitQFC2023-02-13
3441751819355247K2228593M 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
3441721819355247K2228593M 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
3441751817512996K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing KitOMP2023-03-23
3441721817512996K2215853M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing KitOMP2023-03-23
3441751799147345K220660Prevena Restor Adapti-Form DressingOMP2022-07-01
3441721799147345K220660Prevena Restor Adapti-Form DressingOMP2022-07-01
3441751308290063K220560Dermatac DrapeOMP2022-07-14
3441721308290063K220560Dermatac DrapeOMP2022-07-14
3441751891173139K212320Dermatac™ 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
3441721891173139K212320Dermatac™ 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
3441752003361648K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2021-10-27
3441722003361648K203316V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2021-10-27
3441751557934940K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemOMP2020-07-08
3441721557934940K201571ACTIV.A.C. Negative Pressure Wound Therapy SystemOMP2020-07-08
2347061087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
2347071087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
3441751087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
3441721087308303K183543ACTIV.A.C. Therapy UnitOMP2019-03-20
2347061172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
2347071172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
3441751172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
3441721172662019K181507PREVENA RESTOR(TM) Incision Management SystemOMP2019-02-15
2347061509840358K181505V.A.C. DERMATAC DrapeOMP2019-03-28
2347071509840358K181505V.A.C. DERMATAC DrapeOMP2019-03-28
2347061424452243K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemOMP2018-06-01
2347071424452243K180855Prevena Plus Incision Management System, Prevena Plus Duo Incision Management SystemOMP2018-06-01
2347071274760782K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02
2347061274760782K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02
3441751274760782K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02
3441721274760782K173447V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy UnitOMP2018-03-02
2347061817889821K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemOMP2018-03-09
2347071817889821K173426PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management SystemOMP2018-03-09
2347061244653294K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2017-01-26
2347071244653294K162790V.A.C.ULTA Negative Pressure Wound Therapy SystemOMP2017-01-26
2347061141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
2347071141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
3441751141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
3441721141850329K161897PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE DressingsOMP2016-10-04
2347061586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
2347071586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
3441721586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
3441751586746400K160487V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) SystemOMP2016-12-09
2347061171345257K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...OMP2016-06-20
2347071171345257K160451V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...OMP2016-06-20
2347061497184851K153199Prevena 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
2347071497184851K153199Prevena 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
3441751497184851K153199Prevena 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
3441721497184851K153199Prevena 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
2347061556321095K151710SNaP Wound Care SystemOKO2015-11-19
2347071556321095K151710SNaP Wound Care SystemOKO2015-11-19
3441751556321095K151710SNaP Wound Care SystemOKO2015-11-19
3441721556321095K151710SNaP Wound Care SystemOKO2015-11-19
3441751655254172K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable DressingOMP2015-11-06
3441721655254172K150006Prevena Incision Management System with Peel & Place Dressing, Prevena Incision Management System with Customizable DressingOMP2015-11-06
2347061181701807K142272SNaP Wound Care SystemOKO2014-11-25
2347071181701807K142272SNaP Wound Care SystemOKO2014-11-25
2347062041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
2347072041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
3441752041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
3441722041111306K141017PREVENA INCISION MANAGEMENT SYSTEM WITH PEEL & DRESSING, PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING,OMP2015-08-20
2347071400821657K133276V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESSOMP2013-11-19
2347061400821657K133276V.A.C. GRANUFOAM DRESSING, GRANUFOAM THIN DRESSING, GRANUFOAM ROUND DRESSING, GRANUFOAM SILVER DRESSING, WHITEFOAM DRESSOMP2013-11-19
2347072024830014K133137CISNAP CLOSED INCISION SYSTEMOKO2014-02-25
2347062024830014K133137CISNAP CLOSED INCISION SYSTEMOKO2014-02-25
2347061804363628K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2013-11-15
2347071804363628K132741V.A.C. VIA NEGATIVE PRESSURE WOUND THERAPY SYSTEMOMP2013-11-15
2347061254910489K132080SNAP WOUND CARE SYSTEMOKO2014-03-12
2347071254910489K132080SNAP WOUND CARE SYSTEMOKO2014-03-12
2347061003651056K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGOMP2013-01-15
2347071003651056K123878PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSINGOMP2013-01-15
2347071116450263K123507KCI NPWT GAUZE DRESSINGOMP2013-04-04
2347061116450263K123507KCI NPWT GAUZE DRESSINGOMP2013-04-04
2347071513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
2347061513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
3441751513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
3441721513200542K121883PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA CUSTOMIZABLE DRESSING KITOMP2012-10-11
2347061260686614K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMOMP2012-10-05
2347071260686614K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMOMP2012-10-05
3441751260686614K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMOMP2012-10-05
3441721260686614K120499ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEMOMP2012-10-05
2347071687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
2347061687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
3441751687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
3441721687136164K120033ACTIVAC THERAPY UNIT AND INFOVAC THERAPY UNIT, VAC ATS THERAPY UNIT AND VAC FREEDOM THERAPY UNIT, VAC VIA THERAPY UNITOMP2012-05-31
2347061904380567K113032SNAP WOUND CARE SYSTEMOKO2011-12-01
2347071904380567K113032SNAP WOUND CARE SYSTEMOKO2011-12-01
2347061563462745K112341SNAP WOUND CARE SYSTEMOKO2011-08-29
2347071563462745K112341SNAP WOUND CARE SYSTEMOKO2011-08-29
2347071167757875K111393SNAP (R) WOUND CARE SYSTEMOKO2011-07-28
2347061167757875K111393SNAP (R) WOUND CARE SYSTEMOKO2011-07-28
2347071482904268K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNITOMP2011-07-21
2347061482904268K111280V.A.C. 125 NEGATIVE PRESSURE WOUND THERAPY UNITOMP2011-07-21
2347061006798946K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEMOMP2011-03-14
2347071006798946K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEMOMP2011-03-14
3441751006798946K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEMOMP2011-03-14
3441721006798946K103156V.A.C. VERAFLO CLEANSE DRESSING SYSTEMOMP2011-03-14
2347071337359578K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSINGOMP2010-12-15
2347061337359578K102956V.A.C. GRANUFOAM SILVER SMALL DRESSING; V.A.C. GRANUFOAM SILVER MEDIUM DRESSING; V.A.C. GRANUFOAM SILVER LARGE DRESSINGOMP2010-12-15
2347061659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
2347071659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
3441751659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
3441721659570439K100821PREVENA INCISION MANAGEMENT SYSTEMOMP2010-06-11
2347061659207151K100657V.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
2347071659207151K100657V.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
3441751659207151K100657V.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
3441721659207151K100657V.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
2347061512010664K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM DOMP2010-03-10
2347071512010664K093526V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM DOMP2010-03-10
2347071181456266K090489ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026FTL2009-05-14
2347061181456266K090489ABTHERA OPEN ABDOMEN DRESSING, MODEL: M8275026FTL2009-05-14
2347061607097090K083357OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510OMP2009-03-04
2347071607097090K083357OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM, MODEL 370502, CANISTER, MODEL 370510OMP2009-03-04
2347061836099081K081363NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSINGFRO2008-09-24
2347071160854755K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766OMP2007-06-07
2347061160854755K063740V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766OMP2007-06-07

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OMP1022024-05-23
OKO182015-11-19
QFC42023-02-13
FRO42008-09-24
FTL22009-05-14
KGN22002-02-14

PMN#

GUDID#

200 records. Showing 1-40. Next