← Back to catalogue

Evolution 2

FDA UDI

Class II (US FDA UDI)

by Thermotek, Inc.

Identity

Trade Name
Evolution 2 FDA UDI
Generic Name
Single-chamber venous compression system garment, single-use FDA UDI
Device Name
Evolution, DVT, EV0001, Qty 1 FDA UDI
Model / Reference
0V12X1009M01 FDA UDI
Description
Evolution, DVT, EV0001, Qty 1 FDA UDI

Identifiers

Catalog Number
0V12X1009M01 FDA UDI
Primary DI / UDI-DI
00850033615005 FDA UDI
510(k) Number
K160318 FDA UDI
FDA Product Code
JOW FDA UDI
GMDN Term
Single-chamber venous compression system garment, single-use FDA UDI

Classification

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

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

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: Single-chamber venous compression system garment, single-use

Evolution 2 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, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Thermotek, Inc.

Sources (1)

  • FDA UDI 03bd0189-4562-4958-8766-d28bd103c27f 36 fields · synced Jun 8, 2026