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ARTEK SPORT-01 w UNIV-01, Qty 1

FDA UDI

Class II (US FDA UDI)

by Thermotek, Inc.

Identity

Trade Name
ARTEK SPORT-01 w UNIV-01, Qty 1 FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Device Name
ARTEK SPORT-01 w UNIV-01, Qty 1 FDA UDI
Model / Reference
0V9PTSPRT01UNV01 FDA UDI
Description
ARTEK SPORT-01 w UNIV-01, Qty 1 FDA UDI

Identifiers

Catalog Number
0V9PTSPRT01UNV01 FDA UDI
Primary DI / UDI-DI
00850033615012 FDA UDI
FDA Product Code
ILO 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
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-use

ARTEK SPORT-01 w UNIV-01, Qty 1 by Thermotek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-fluid localized thermal therapy system pack, 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 d3f859eb-ec10-4eb3-ae44-acf41ccf8675 35 fields · synced Jun 8, 2026