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 Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit Circulating-fluid localized thermal therapy system control unit

• Primary Device ID: 10613031861938
• NIH Device Record Key: aa37c821-752d-4456-b1d2-84ad197dfefd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electri-Cool ll
• Version Model Number: 767
• Catalog Number: 86193
• Company DUNS: 004249462
• Company Name: Gentherm Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com
• Phone: 8009897373
• Email: csz@genthermcsz.com

Device Dimensions

• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch
• Weight: 13 Pound
• Depth: 6 Inch
• Width: 12 Inch
• Height: 12 Inch

Operating and Storage Conditions

• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Celsius and 50 Degrees Celsius
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031861938 [Primary]

FDA Product Code

• ILO: Pack, Hot Or Cold, Water Circulating

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2021-09-23
• Device Publish Date: 2016-05-18

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