TECOtherm 8289830

GUDID 04260647540314

Tec Com Medizintechnik GmbH

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: 04260647540314
• NIH Device Record Key: 146b4f7c-fea0-4545-8970-dc01296a8b4a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TECOtherm
• Version Model Number: NEO
• Catalog Number: 8289830
• Company DUNS: 315215424
• Company Name: Tec Com Medizintechnik GmbH
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH
• Phone: +493451205204
• Email: service@TCM.GmbH

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260647540314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140078

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: 2024-05-02
• Device Publish Date: 2024-04-24

Devices Manufactured by Tec Com Medizintechnik GmbH

• 04260647540314 - TECOtherm: 2024-05-02
• 04260647540314 - TECOtherm: 2024-05-02
• 04260647540031 - TCmatt: 2024-04-26 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an
• 04260647540017 - TCmatt: 2020-11-30 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an