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Maxi-Therm®Lite

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
Maxi-Therm®Lite FDA UDI
Generic Name
External circulating-fluid core temperature regulation system pad, single-use FDA UDI
Device Name
Hyper-Hypothermia Blanket FDA UDI
Model / Reference
876 FDA UDI
Description
Hyper-Hypothermia Blanket FDA UDI

Identifiers

Catalog Number
82876 FDA UDI
Primary DI / UDI-DI
20613031828761 FDA UDI
FDA Product Code
ILO FDA UDI
GMDN Term
External circulating-fluid core temperature regulation system pad, 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 9.34 Pound FDA UDI
Width — 25.0 Inch FDA UDI
Length — 64.0 Inch FDA UDI

Category: External circulating-fluid core temperature regulation system pad, single-use

Maxi-Therm®Lite by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-fluid core temperature regulation system pad, 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 6cb77483-5baf-4fb1-9f48-c5cc14867170 37 fields · synced May 30, 2026