FDA.reportPublic FDA data

Vcare Alpha

Primary DI
07290111490002
Brand
Vcare Alpha
Company
I.V.T. MEDICAL LTD
Model
Vcare α® Device
Catalog number
VCA233e
Device description
Electric, reusable powered suction pump for Regulated Oxygen-Enriched Negative Pressure wound Therapy (ROI-NPT). Intended for management of complex wounds. Prescription use only.
Published
2017-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1
OMPNegative Pressure Wound Therapy Powered Suction PumpGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121817000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121817000VCARE AIVT Medical, Ltd.2013-09-17OMP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290111490002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290111490002072901114900027290111490002

GMDN Terms#

Term, Definition table
TermDefinition
Negative-pressure wound therapy system, line-poweredAn assembly of devices designed to treat hard-to-heal open wounds (e.g., acute, traumatic, and chronic), burns, diabetic/pressure ulcers, flaps, and grafts with suction. It typically consists of a dressing (e.g., open-cell foam or medicated gauze), an airtight adhesive drape, an evacuation tube, a collection canister, and a mains electricity (AC-powered) computer-controlled vacuum pump. The pump applies continuous or intermittent negative pressure to the wound via the tube to the dressing which decompresses capillaries/lymphatic vessels, improves blood/interstitial fluid circulation, draws wound edges together, facilitates granulation tissue formation, and prepares the wound bed for closure.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
514996339
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290111491009Vcare AlphaWound Dressing Kit 10x10SWDK10102017-08-13
07290111491108Vcare AlphaWound Dressing Kit 10x20SWDK10202017-08-13
07290111491207Vcare AlphaWound Dressing Kit 15x20SWDK15202017-08-13
07290111491306Vcare AlphaWound Dressing Kit 20x30SWDK 20302017-08-13
07290111491405Vcare AlphaWoind Dressing Kit 40x45SWDK40452017-08-13
07290111492006Vcare AlphaSponge Accessory Pack 10x102017-08-13
07290111492105Vcare AlphaSponge Accessory Pack 10x202017-08-13
07290111492204Vcare AlphaSponge Accessory Pack 15x202017-08-13
07290111492303Vcare AlphaSponge Accessory Pack 20x302017-08-13
07290111492402Vcare AlphaSponge Accessory Pack 40x452017-08-13
07290111493003Vcare AlphaROI-NPT Wound Dressing Kit 20x302017-08-13
07290111493102Vcare AlphaROI-NPT Wound Dressing Kit 40x452017-08-13
07290111494000Vcare AlphaIrrigation hose adapter accessory kitACC-IHF2017-08-13
07290111494109Vcare AlphaHose Adapter Accessory kitACC-HAPT2017-08-13
07290111494208Vcare AlphaDrape Accessory PackACC-5DRS2017-08-13
07290108154108TopClosure3S-M Rescue Kit 8mm3SM-R-SBL8-GI2018-11-13
07290111495007Vcare AlphaProximal TubeSPT1702017-08-13
07290111495106Vcare AlphaCollecting CanisterCC8002017-08-13
07290111495205Vcare AlphaCollecting Canister + Proximal Tube2017-08-13
07290108154009TopClosure 1S-M Rescue Kit 8mm1SM-R-SBL8-GI2017-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00197998382895Solventum™ Veraflo™ Cleanse Choice™Solventum US LLCOMP2026-05-28
00749756392495DeRoyalDEROYAL INDUSTRIES, INC.OMP2026-01-22
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
00749756390194DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390200DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
00749756390217DeRoyalDEROYAL INDUSTRIES, INC.OMP2024-05-08
108495540138623M™ V.A.C.®KCI USA, INC.OMP2024-03-05
108495540138793M™ V.A.C.®KCI USA, INC.OMP2024-03-05
108495540138863M™ V.A.C.®KCI USA, INC.OMP2024-03-05
00749756387828DeRoyalDEROYAL INDUSTRIES, INC.OMP2023-12-20
00749756387880DeRoyalDEROYAL INDUSTRIES, INC.OMP2023-12-20
00749756387897DeRoyalDEROYAL INDUSTRIES, INC.OMP2023-12-20
00749756387903DeRoyalDEROYAL INDUSTRIES, INC.OMP2023-12-20
00749756392464DeRoyalDEROYAL INDUSTRIES, INC.OMP2023-11-23
25060826400056NEXA DrapeNEXA MEDICAL LIMITEDOMP2023-08-30
25060826400063Nexa FoamNEXA MEDICAL LIMITEDOMP2023-08-30
35060826400015NEXA NPWT DRESSING -125mmHgNEXA MEDICAL LIMITEDOMP2023-08-30
35060826400039NEXA NPWT FLUID CONTAINER PACKNEXA MEDICAL LIMITEDOMP2023-08-30