← Back to catalogue

FilteredFlo® Lower Body OR Blanket

FDA UDI

Class II (US FDA UDI)

by Gentherm Medical, LLC

Identity

Trade Name
FilteredFlo® Lower Body OR Blanket FDA UDI
Generic Name
External circulating-air core temperature regulation system pad, single-use FDA UDI
Device Name
WarmAir 135 patient warming system. FDA UDI
Model / Reference
442 FDA UDI
Description
WarmAir 135 patient warming system. FDA UDI

Identifiers

Catalog Number
83442 FDA UDI
Primary DI / UDI-DI
20613031834427 FDA UDI
FDA Product Code
DWJ FDA UDI
GMDN Term
External circulating-air core temperature regulation system pad, single-use 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

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
Width — 40.0 Inch FDA UDI
Length — 53.0 Inch FDA UDI

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

FilteredFlo® Lower Body OR Blanket by Gentherm Medical, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External circulating-air core temperature regulation system pad, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Gentherm Medical, LLC

Sources (1)

  • FDA UDI ff5db064-2a0c-4978-927b-1a664709121c 37 fields · synced May 30, 2026