TCmatt 6426801

GUDID 04260647540031

Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.

Tec Com Medizintechnik GmbH

External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable External circulating-fluid core temperature regulation system pad, reusable

• Primary Device ID: 04260647540031
• NIH Device Record Key: f47f1f92-5b84-4efe-bce4-ff70a6f87126
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TCmatt
• Version Model Number: NEOmulti
• Catalog Number: 6426801
• Company DUNS: 315215424
• Company Name: Tec Com Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	04260647540031 [Primary]

FDA Product Code

• FOH: Mattress, Water, Temperature Regulated

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: 2024-04-26
• Device Publish Date: 2024-04-18

On-Brand Devices [TCmatt]

• 04260647540017: Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of p
• 04260647540031: Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of p