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
Primary Device ID04260647540031
NIH Device Record Keyf47f1f92-5b84-4efe-bce4-ff70a6f87126
Commercial Distribution StatusIn Commercial Distribution
Brand NameTCmatt
Version Model NumberNEOmulti
Catalog Number6426801
Company DUNS315215424
Company NameTec Com Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH
Phone+493451205204
Emailservice@TCM.GmbH

Device Identifiers

Device Issuing AgencyDevice ID
GS104260647540031 [Primary]

FDA Product Code

FOHMattress, Water, Temperature Regulated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-26
Device Publish Date2024-04-18

On-Brand Devices [TCmatt]

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

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