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Vcare Alpha

FDA UDI

Class I (US FDA UDI)

by IVT Medical, Ltd.

Identity

Trade Name
Vcare Alpha FDA UDI
Generic Name
Negative-pressure wound therapy system, electric, reusable FDA UDI
Model / Reference
Wound Dressing Kit 20x30 FDA UDI

Identifiers

Catalog Number
SWDK 2030 FDA UDI
Primary DI / UDI-DI
07290111491306 FDA UDI
FDA Product Code
MKY FDA UDI
GMDN Term
Negative-pressure wound therapy system, electric, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4320 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Negative-pressure wound therapy system, electric, reusable

Vcare Alpha by IVT Medical, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Negative-pressure wound therapy system, electric, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
IVT Medical, Ltd.

Sources (1)

  • FDA UDI 76c244f1-f29a-40b2-90fd-4545fc74d83c 33 fields · synced May 30, 2026