AccessGUDID - DEVICE: TCmatt (04260647540031)

GUDID

Device Identifier (DI) Information

Brand Name: TCmatt
Version or Model: NEOmulti
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 6426801
Company Name: Tec Com Medizintechnik GmbH

Primary DI Number: 04260647540031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315215424 *Terms of Use

Device Description: Mattress to be used with TECOtherm NEO hypothermia system for full body temperature control of patients, principally newborns and 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:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
36854	External circulating-fluid core temperature regulation system pad, reusable	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FOH	Mattress, Water, Temperature Regulated

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: f47f1f92-5b84-4efe-bce4-ff70a6f87126
Public Version Date: April 26, 2024
Public Version Number: 1
DI Record Publish Date: April 18, 2024