FDA.reportPublic FDA data

TECOtherm Wrabbit

Primary DI
04260647540215
Brand
TECOtherm Wrabbit
Company
Tec Com Medizintechnik GmbH
Model
S
Device description
The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.
Published
2024-10-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMEBedding, Disposable, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMEBedding, Disposable, MedicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260647540253PackageGS110In Commercial Distribution
04260647540284PackageGS110In Commercial Distribution
04260647540215PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260647540253042606475402534260647540253
04260647540284042606475402844260647540284
04260647540215042606475402154260647540215

GMDN Terms#

Term, Definition table
TermDefinition
Infant heat shieldA protective guard intended to be used to reduce heat loss due to insensible water loss, i.e., evaporation, during the radiant warming of primarily premature infants. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315215424
Device count
1
Premarket exempt
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
04260647540277TECOtherm WrabbitL2024-10-02
04260647540260TECOtherm WrabbitM2024-10-02
04260647540017TCmattNEOsingle64274012020-11-20
04260647540314TECOthermNEO82898302024-04-24
04260647540031TCmattNEOmulti64268012024-04-18

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00199536911130BluelineTransparent Supply Solutions Ltd.KME2026-05-15
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