FilteredFlo® Pediatric Blanket 84244

GUDID 10613031842449

Thermal Regulating System

Gentherm Medical, LLC

Circulating-air whole-body heating/cooling system pad, single-use, non-sterile
Primary Device ID10613031842449
NIH Device Record Keyb36e032f-037b-473c-9b20-84e77d3bf3a6
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilteredFlo® Pediatric Blanket
Version Model Number244
Catalog Number84244
Company DUNS004249462
Company NameGentherm Medical, LLC
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
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
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
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
Phone1-800-989-7373
Emailcsz@genthermcsz.com
Phone1-800-989-7373
Emailcsz@genthermcsz.com

Device Dimensions

Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound
Width40 Inch
Length55 Inch
Weight0.3 Pound

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
Storage Environment TemperatureBetween -40 Degrees Celsius and 50 Degrees Celsius
Handling Environment TemperatureBetween 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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 60.8 Degrees Fahrenheit and 75.2 Degrees Fahrenheit
Handling Environment TemperatureBetween 16 Degrees Celsius and 24 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110613031842449 [Unit of Use]
GS120613031842446 [Primary]

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-30
Device Publish Date2022-08-22

On-Brand Devices [FilteredFlo® Pediatric Blanket]

10613031842449Thermal Regulating System
10613031812442Thermal Regulating System

Trademark Results [FilteredFlo]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILTEREDFLO
FILTEREDFLO
74373492 1889211 Live/Registered
GENTHERM MEDICAL, LLC
1993-03-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.