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WarmAir® 135

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
WarmAir® 135 FDA UDI
Generic Name
Circulating-air whole-body heating system control unit FDA UDI
Device Name
Convective Warming System FDA UDI
Model / Reference
135 FDA UDI
Description
Convective Warming System FDA UDI

Identifiers

Catalog Number
86386 FDA UDI
Primary DI / UDI-DI
10613031863864 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
Circulating-air whole-body heating system control unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5900 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Dimensions & Sizes

Size
Weight — 6.1 Kilogram FDA UDI
Weight — 13.5 Pound FDA UDI
Height — 34.29 Centimeter FDA UDI
Depth — 22.2 Centimeter FDA UDI
Width — 22.2 Centimeter FDA UDI
Height — 13.5 Inch FDA UDI
Depth — 8.75 Inch FDA UDI
Width — 8.75 Inch FDA UDI

Category: Circulating-air whole-body heating system control unit

WarmAir® 135 by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Circulating-air whole-body heating system control unit.

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 2b3c5842-4bbb-4029-80d7-5fb27b8faf23 36 fields · synced Jun 1, 2026