FDA.reportPublic FDA data

INFOV.A.C.™

Primary DI
00849554001534
Brand
INFOV.A.C.™
Company
KCI USA, INC.
Model
M8259999
Device description
Infovac Therapy System
Published
2016-09-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
OMPNegative Pressure Wound Therapy Powered Suction Pump

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063740000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063740000V.A.C. THERAPY SYSTEMS - INFO V.A.C. THERAPY UNIY, MODEL M6257766Kci USA, Inc.2007-06-07OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00849554006799Direct MarkingGS10
00849554001534PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00849554006799008495540067998495540067990849554006799
00849554001534008495540015348495540015340849554001534

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system pump, electricA mains electricity (AC-powered) device intended to create and control negative pressure in a vacuum-assisted wound closure system during negative pressure wound therapy (NPWT) for the treatment of hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps and grafts. It is typically a computer-controlled vacuum pump with controls and display for continuous or intermittent negative pressure delivered through a tubing set to the open-cell foam dressing located at the airtight-sealed wound. It typically has internal batteries that allow the device to operate for a short period without line power (e.g., during transport or a power outage).

Regulatory Flags#

DUNS number
102726734
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998301148Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998301162Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998303906Solventum™ ActiV.A.C.™M8275058/5 M8275058/10M8275058/5 M8275058/102026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™M8275065/5M8275065/52026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™M8275065/5 M8275065/10M8275065/5 M8275065/102026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™M8275081/5 M8275081/10M8275081/5 M8275081/102026-07-22
00849554005532SNAP™ STPAL2016-09-24
00849554005549SNAP™ STPALP2016-09-24
00849554005563SNAP™ STPASP2016-09-24
00849554005570SNAP™ STPAMP2016-09-24
00849554005587SNAP™ STPAS2016-09-24
108495540138623M™ V.A.C.®EZ5SMLV001 / EZ5SMLV002EZ5SML2024-03-05
108495540138793M™ V.A.C.®EZ5MEDV001 / EZ5MEDV002EZ5MED2024-03-05
108495540138863M™ V.A.C.®EZ5LRGV001 / EZ5LRGV002EZ5LRG2024-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998301148Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998301162Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998303906Solventum™ ActiV.A.C.™KCI USA, INC.OMP2026-07-23
00197998276507Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300912Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998300936Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313660Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313691Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313752Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313783Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313844Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00197998313905Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-07-22
00840117350984Durma+ Flexible Suction Bell, With TubingDynarex CorporationOMP2026-06-22
00197998382819Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
00849405002673Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002680Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
00849405002697Hybrid Dressing - RevoGENADYNE BIOTECHNOLOGIES INC.OMP2026-01-12
08718104890947Endo-SPONGE PumpMeditop B.V.OMP2025-10-17
00197998028922Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998028946Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998032608Solventum US LLCKCI USA, INC.OMP2025-07-29
00197998312267Solventum US LLCKCI USA, INC.OMP2025-07-29
10851978007662WoundPro+ Collection CanisterPensar Medical, LLCOMP2025-03-18
10851978007679WoundPro+ 300cc Advanced Canister w/8' TubingPensar Medical, LLCOMP2025-03-18
10851978007631WoundPro+ 300cc Advanced Canister w/5' TubingPensar Medical, LLCOMP2025-01-14
07612367016940Invia Liberty Carrying CaseMedela AGOMP2024-10-11
07612367060509Invia Motion Carrying CaseMedela AGOMP2024-10-11
07612367038713Standard rail universal holderMedela AGOMP2024-06-03