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Cold Therapy Temp-Pads®

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Cold Therapy Temp-Pads® FDA UDI
Generic Name
Circulating-fluid localized thermal therapy system pack, single-use FDA UDI
Device Name
Water Circulating Hot or Cold Pack FDA UDI
Model / Reference
814-US FDA UDI
Description
Water Circulating Hot or Cold Pack FDA UDI

Identifiers

Catalog Number
50627 FDA UDI
Primary DI / UDI-DI
20613031506270 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

Yes

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 8.0 Inch FDA UDI
Length — 14.0 Inch FDA UDI
Weight — 0.32 Pound FDA UDI

Category: Circulating-fluid localized thermal therapy system pack, single-use

Cold Therapy Temp-Pads® by Gentherm Medical, LLC — 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
Gentherm Medical, LLC

Sources (1)

  • FDA UDI 061cd85a-b7b4-4e7b-b2b9-dbd2f168190e 37 fields · synced May 30, 2026