FDA.reportPublic FDA data

NA

Primary DI
04713616090278
Brand
NA
Company
CARILEX MEDICAL, INC.
Model
S1001-6020
Device description
Canister for VT•100 - 500ml lock
Published
2017-03-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral Hospital2
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112853000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112853000VOLTERA POWERED SUCTION PUMPSuzric Enterprise Co., Ltd.2012-11-09OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04713616090278PackageGS15In Commercial Distribution
04713616094702PackageGS18In Commercial Distribution
04719873693818PackageGS112In Commercial Distribution
14713616093610PackageGS15In Commercial Distribution
24713616093617PackageGS112In Commercial Distribution
04713616093613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04713616090278047136160902784713616090278
04713616094702047136160947024713616094702
04719873693818047198736938184719873693818
1471361609361014713616093610
2471361609361724713616093617
04713616093613047136160936134713616093613

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
658863238
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
04719873697724NAS1001-10102026-08-26
04719873697731NAS1001-10202026-08-26
04719873697748NAS1001-10302026-08-26
04719873697755NAS1001-10402026-08-26
04719873697762NAS1001-10502026-08-26
04719873697779NAS1001-10602026-08-26
04719873697786NAS1001-10702026-08-26
04719873697793NAS1001-10802026-08-26
04719873697809NAS1001-10902026-08-26
04719873697816NAS1001-11002026-08-26
04719873697823NAS1001-11102026-08-26
04719873698622NAS2003-A3002025-12-22
04719873698639NAS2003-A3102025-12-22
04719873698608NAS2003-22502025-12-22
04719873698615NAS2003-22602025-12-22
14719873698629NAS2003-A3002025-12-22
14719873698636NAS2003-A3102025-12-22
04713616090230NAS1001-20502018-12-05
04713616090247NAS1001-20602018-11-28
04713616091336NAS1001-21002021-03-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850084501920Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501937Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501944Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00850084501951Viz™ Wound Visualization Negative Pressure Wound Therapy SystemNEW HORIZON HEALTHCARE MANAGEMENT LLCOMP2026-09-24
00749756985475DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985963DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756985994DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756986250DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-21
00749756401289DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401692DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
00749756401746DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-09-18
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
14026704911773PLEUR-EVACTELEFLEX INCORPORATEDKDQ2026-08-01
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