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VascuTherm4

FDA UDI

Class II (US FDA UDI)

by Thermotek, Inc.

Identity

Trade Name
VascuTherm4 FDA UDI
Generic Name
Single-chamber venous compression system garment, reusable FDA UDI
Device Name
VascuTherm4 Therapy System FDA UDI
Model / Reference
0P9PTVT400 FDA UDI
Description
VascuTherm4 Therapy System FDA UDI

Identifiers

Catalog Number
0P9PTVt400 FDA UDI
Primary DI / UDI-DI
B5850P9PTVT4000 FDA UDI
FDA Product Code
JOW FDA UDI
ILO FDA UDI
GMDN Term
Single-chamber venous compression system garment, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5800 FDA UDI
890.5720 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, single-useCirculating-fluid localized thermal/compression therapy system wrapCirculating-fluid localized thermal/compression therapy system control unitSingle-chamber venous compression system garment, reusable

VascuTherm4 by Thermotek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Single-chamber venous compression system garment, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thermotek, Inc.

Sources (1)

  • FDA UDI 0c24e989-2765-45e0-9b0c-e6ee0e3b30d6 35 fields · synced May 29, 2026