Electri-Cool ll 86193

GUDID 10613031861938

The Electri-Cool® II System is intended to provide cold therapy.

Gentherm Medical, LLC

Circulating-fluid thermal therapy system control unit
Primary Device ID10613031861938
NIH Device Record Keyaa37c821-752d-4456-b1d2-84ad197dfefd
Commercial Distribution StatusIn Commercial Distribution
Brand NameElectri-Cool ll
Version Model Number767
Catalog Number86193
Company DUNS004249462
Company NameGentherm Medical, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
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

Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com
Phone8009897373
Emailcsz@genthermcsz.com

Device Dimensions

Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch
Weight13 Pound
Depth6 Inch
Width12 Inch
Height12 Inch

Operating and Storage Conditions

Handling Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Handling Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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
Storage 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110613031861938 [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 Date2016-05-18

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