FDA.reportPublic FDA data

INFOV.A.C.™

Primary DI
00849554006799
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
OTC
false
Sterile
false
Single use
false

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
102726734
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00197998301209Solventum™ V.A.C.® Granufoam™M8275053/5 M8275053/10M8275053/5 M8275053/102026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™M8275052/5 M8275052/10M8275052/5 M8275052/102026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™M8275051/5 M8275051/10M8275051/5 M8275051/102026-08-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719873697724NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697731NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697748NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697755NACARILEX MEDICAL, INC.OMP2026-08-26
04719873697762NACARILEX MEDICAL, INC.OMP2026-08-26
00197998301209Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301285Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00197998301360Solventum™ V.A.C.® Granufoam™KCI USA, INC.OMP2026-08-07
00850084501005Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501029Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501036Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501043Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501050Viz™ Wound DressingNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
00850084501067Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-07-28
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