WarmAir® 135 86186

GUDID 10613031861860

Convective Warming System

Gentherm Medical, LLC

Circulating-air whole-body heating system control unit

• Primary Device ID: 10613031861860
• NIH Device Record Key: cba8f466-f8f2-4d19-b285-dbd45ecac690
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WarmAir® 135
• Version Model Number: 135
• Catalog Number: 86186
• 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: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com
• Phone: 1-800-989-7373
• Email: csz@genthermcsz.com

Device Dimensions

• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch
• Weight: 6.1 Kilogram
• Weight: 13.5 Pound
• Height: 34.29 Centimeter
• Depth: 22.2 Centimeter
• Width: 22.2 Centimeter
• Height: 13.5 Inch
• Depth: 8.75 Inch
• Width: 8.75 Inch

Operating and Storage Conditions

• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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 60 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031861860 [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: 2016-08-29

On-Brand Devices [WarmAir® 135]

• 10613031861860: Convective Warming System
• 10613031863864: Convective Warming System