AccessGUDID - DEVICE: TECOtherm Wrabbit (04260647540215)

GUDID

Device Identifier (DI) Information

Brand Name: TECOtherm Wrabbit
Version or Model: S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Tec Com Medizintechnik GmbH

Primary DI Number: 04260647540215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315215424 *Terms of Use

Device Description: The TECOtherm Wrabbit is designed as a disposable device to help prevent postnatal heat and water loss in premature and newborn infants.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15752	Infant heat shield	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KME	Bedding, Disposable, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f681e4b-07e1-451b-86ae-a48ba045ed20
Public Version Date: October 10, 2024
Public Version Number: 1
DI Record Publish Date: October 02, 2024