Cold Therapy Temp-Pads® 50715

GUDID 10613031507157

Water Circulating Hot or Cold Pack

Gentherm Medical, LLC

Circulating-fluid thermal therapy system pack, single-use
Primary Device ID10613031507157
NIH Device Record Key2530a476-619d-4db8-80a4-301d79322dcc
Commercial Distribution StatusIn Commercial Distribution
Brand NameCold Therapy Temp-Pads®
Version Model NumberN/A
Catalog Number50715
Company DUNS004249462
Company NameGentherm Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Countertrue

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

Device Dimensions

Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch
Weight0.34 Pound
Width11 Inch
Length12 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110613031507157 [Primary]

FDA Product Code

ILOPack, Hot Or Cold, Water Circulating

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 Date2016-09-12

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