Vcare Alpha SWDK4045

GUDID 17290111491402

I.V.T. MEDICAL LTD

Negative-pressure wound therapy system, line-powered
Primary Device ID17290111491402
NIH Device Record Key0ee59394-959f-4370-875a-3d06f47b9904
Commercial Distribution StatusIn Commercial Distribution
Brand NameVcare Alpha
Version Model NumberWoind Dressing Kit 40x45
Catalog NumberSWDK4045
Company DUNS514996339
Company NameI.V.T. MEDICAL LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290111491405 [Primary]
GS117290111491402 [Package]
Contains: 07290111491405
Package: Distribution Carton [12 Units]
In Commercial Distribution

FDA Product Code

MKYSystem, Skin Closure

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-08-13

On-Brand Devices [Vcare Alpha]

07290111495205Collecting Canister + Proximal Tube
07290111495106Collecting Canister
07290111495007Proximal Tube
17290111494205Drape Accessory Pack
17290111494106Hose Adapter Accessory kit
17290111494007Irrigation hose adapter accessory kit
17290111493109ROI-NPT Wound Dressing Kit 40x45
17290111493000ROI-NPT Wound Dressing Kit 20x30
17290111492409Sponge Accessory Pack 40x45
17290111492300Sponge Accessory Pack 20x30
17290111492201Sponge Accessory Pack 15x20
17290111492102Sponge Accessory Pack 10x20
17290111492003Sponge Accessory Pack 10x10
17290111491402Woind Dressing Kit 40x45
17290111491303Wound Dressing Kit 20x30
17290111491204Wound Dressing Kit 15x20
17290111491105Wound Dressing Kit 10x20
17290111491006Wound Dressing Kit 10x10
07290111490002Vcare α® Device

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