Kool-Kit 900-USME

GUDID 10613031839005

Thermal Regulation Pad

Gentherm Medical, LLC

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

• Primary Device ID: 10613031839005
• NIH Device Record Key: 7961abc0-aeb7-44d8-bade-694b7ec4e3bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Kool-Kit
• Version Model Number: 900-USME
• Catalog Number: 900-USME
• Company DUNS: 004249462
• Company Name: Gentherm Medical, LLC
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound
• Depth: 3 Inch
• Length: 14.25 Inch
• Width: 11 Inch
• Weight: 0.96 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	10613031839005 [Unit of Use]
GS1	20613031839002 [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 [Kool-Kit ]

• 10613031839500: Body Temperature Regulation Pad
• 10613031839302: Thermal Regulation Pad
• 10613031839203: Thermal Regulation Pad
• 10613031839005: Thermal Regulation Pad