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Artek Pro-01

FDA UDI

Class II (US FDA UDI)

by Thermotek, Inc.

Identity

Trade Name
ARTEK PRO-01 FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Device Name
ARTEK PRO-01 W/UNV WRAP, COMP01 FDA UDI
Model / Reference
0P9PTATP01UNVWRC01 FDA UDI
Description
ARTEK PRO-01 W/UNV WRAP, COMP01 FDA UDI

Identifiers

Catalog Number
0P9PTATP01UNVWRC01 FDA UDI
Primary DI / UDI-DI
00850033615067 FDA UDI
FDA Product Code
ILO FDA UDI
JOW FDA UDI
GMDN Term
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5720 FDA UDI
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: Circulating-fluid localized thermal therapy system pack, single-useSingle-chamber venous compression system garment, single-use

Artek Pro-01 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

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Manufacturer

Manufacturer
Thermotek, Inc.

Sources (1)

  • FDA UDI 502c6adc-8509-4de8-98bd-639deb8f7b44 35 fields · synced May 30, 2026