InnerCool® STx™ System 86000

GUDID 10613031860009

Temperature management system used to lower or raise a patient's temperature and/or maintain a desired patient temperature through conductive heat transfer.

Gentherm Medical, LLC

Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit Circulating-fluid whole-body heating/cooling system control unit External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling External circulating-fluid core temperature regulation system control unit, heating/cooling

• Primary Device ID: 10613031860009
• NIH Device Record Key: cd715d2d-021c-4920-a324-ee89e9073f89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InnerCool® STx™ System
• Version Model Number: 25-01
• Catalog Number: 86000
• Company DUNS: 004249462
• Company Name: Gentherm Medical, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com
• Phone: 800-989-7373
• Email: csz@genthermcsz.com

Device Dimensions

• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch
• Weight: 131 Pound
• Height: 37.5 Inch
• Depth: 17 Inch
• Width: 17 Inch

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031860009 [Primary]

FDA Product Code

• DWJ: System, Thermal Regulating

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: 2016-08-26

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