Maxi-Therm Lite 876-USME

GUDID 10613031838763

Thermal Regulation Pad

Gentherm Medical, LLC

External circulating-fluid core temperature regulation system pad, single-use

• Primary Device ID: 10613031838763
• NIH Device Record Key: 6382be24-361c-4ec1-87e6-117e68f3feb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxi-Therm Lite
• Version Model Number: 876-USME
• Catalog Number: 876-USME
• Company DUNS: 004249462
• Company Name: Gentherm Medical, LLC
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• 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

Device Dimensions

• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound
• Length: 64 Inch
• Width: 25 Inch
• Weight: 9.34 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031838763 [Unit of Use]
GS1	20613031838760 [Primary]

FDA Product Code

• DWJ: System, Thermal Regulating

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-21
• Device Publish Date: 2024-05-13

On-Brand Devices [Maxi-Therm Lite ]

• 10613031838763: Thermal Regulation Pad
• 10613031838749: Thermal Regulation Pad
• 10613031838732: Thermal Regulation Pad