TECOtherm 8289830

GUDID 04260647540314

Tec Com Medizintechnik GmbH

External circulating-fluid core temperature regulation system control unit, heating/cooling
Primary Device ID04260647540314
NIH Device Record Key146b4f7c-fea0-4545-8970-dc01296a8b4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameTECOtherm
Version Model NumberNEO
Catalog Number8289830
Company DUNS315215424
Company NameTec Com Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
GS104260647540314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DWJSystem, Thermal Regulating

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-02
Device Publish Date2024-04-24

Devices Manufactured by Tec Com Medizintechnik GmbH

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04260647540260 - TECOtherm Wrabbit2024-10-10 The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn
04260647540314 - TECOtherm2024-05-02
04260647540314 - TECOtherm2024-05-02
04260647540031 - TCmatt2024-04-26 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an
04260647540017 - TCmatt2020-11-30 Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns an

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