FDA.reportPublic FDA data

TCmatt

Primary DI
04260647540031
Brand
TCmatt
Company
Tec Com Medizintechnik GmbH
Model
NEOmulti
Catalog number
6426801
Device description
Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and infants.
Published
2024-04-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
FOHMattress, Water, Temperature Regulated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FOHMattress, Water, Temperature RegulatedGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647540031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647540031042606475400314260647540031

GMDN Terms#

Term, Definition table
TermDefinition
External circulating-fluid core temperature regulation system pad, reusableAn underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+493451205204service@TCM.GmbH

Regulatory Flags#

DUNS number
315215424
Device count
1
Premarket exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260647540123TECOtherm WrabbitL2024-10-02
04260647540239TECOtherm WrabbitM2024-10-02
04260647540215TECOtherm WrabbitS2024-10-02
04260647540277TECOtherm WrabbitL2024-10-02
04260647540260TECOtherm WrabbitM2024-10-02
04260647540017TCmattNEOsingle64274012020-11-20
04260647540314TECOthermNEO82898302024-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849111076098STX SURFACE COOLING Zoll Circulation, Inc.FOH2024-08-15
00849111076104STX SURFACE COOLING Zoll Circulation, Inc.FOH2024-08-15
00849111076111STX SURFACE COOLINGZoll Circulation, Inc.FOH2024-08-15
04260647540017TCmattTec Com Medizintechnik GmbHFOH2020-11-20
05060206921498TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07
05060206921757TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07
05060206921771TecothermINSPIRATION HEALTHCARE LIMITEDFOH2016-11-07