WarmAir® 135 86186

GUDID 10613031861860

Convective Warming System

Gentherm Medical, LLC

Circulating-air whole-body heating system control unit
Primary Device ID10613031861860
NIH Device Record Keycba8f466-f8f2-4d19-b285-dbd45ecac690
Commercial Distribution StatusIn Commercial Distribution
Brand NameWarmAir® 135
Version Model Number135
Catalog Number86186
Company DUNS004249462
Company NameGentherm Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com

Device Dimensions

Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch
Weight6.1 Kilogram
Weight13.5 Pound
Height34.29 Centimeter
Depth22.2 Centimeter
Width22.2 Centimeter
Height13.5 Inch
Depth8.75 Inch
Width8.75 Inch

Operating and Storage Conditions

Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment HumidityBetween 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 20 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110613031861860 [Primary]

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2021-09-23
Device Publish Date2016-08-29

On-Brand Devices [WarmAir® 135]

10613031861860Convective Warming System
10613031863864Convective Warming System

Trademark Results [WarmAir]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WARMAIR
WARMAIR
74143741 1709298 Live/Registered
GENTHERM MEDICAL, LLC
1991-03-04

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