FDA.reportPublic FDA data

Vcare Alpha

Primary DI
17290111494106
Brand
Vcare Alpha
Company
I.V.T. MEDICAL LTD
Model
Hose Adapter Accessory kit
Catalog number
ACC-HAPT
Published
2017-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MKYSystem, Skin Closure

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKYSystem, Skin ClosureGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290111494106PackageGS140In Commercial Distribution
07290111494109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1729011149410617290111494106
07290111494109072901114941097290111494109

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

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
07290111490002Vcare AlphaVcare α® DeviceVCA233e2017-08-13
07290111495007Vcare AlphaProximal TubeSPT1702017-08-13
07290111495106Vcare AlphaCollecting CanisterCC8002017-08-13
07290111495205Vcare AlphaCollecting Canister + Proximal Tube2017-08-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007834257SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
10860007834254SUTUREGARD® InterlockSUTUREGARD MEDICAL, INCMKY2026-01-09
06972864363024sknjxNingbo Chinmed Technology Co., Ltd.MKY2025-11-20
00844735006728DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
00844735006735DERMACLOSESYNOVIS MICRO COMPANIES ALLIANCE, INCMKY2024-06-27
07540161750015AbCloInventorr MD IncMKY2023-12-04
00840118605175ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611435ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611459ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611473ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611497ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611510ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611534ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611558ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613644ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118605182ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611442ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611466ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611480ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611503ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611527ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611541ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118611565ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
00840118613651ENDURE INDUSTRIESENDURE INDUSTRIESMKY2023-10-15
08800125000020DIALFIX 11DFIXMKY2023-01-28
08800125000037DIALFIX 15DFIXMKY2023-01-28
08800125000044DIALFIX 18DFIXMKY2023-01-28
08800125000051DIALFIX 21DFIXMKY2023-01-28
08800125000068DIALFIX 24DFIXMKY2023-01-28
08800125000075DIALFIX PLUS 3DFIXMKY2023-01-28