AccessGUDID - DEVICE: TRACOE® care (04035324014927)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE® care
Version or Model: REF 903-H-P
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324014927
Issuing Agency: GS1
Commercial Distribution End Date: March 06, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: Neck Strap - 10 units

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):	Yes
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?
35752	Tracheostomy tube neck holder, reusable	A noninvasive device designed to be fastened around the neck of a patient to secure a tracheostomy device (tube, button) in situ. It is typically in the form of a dedicated strap/collar intended to connect to the tracheostomy device, which is not included. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CBH	DEVICE, FIXATION, TRACHEAL TUBE

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
Special Storage Condition, Specify: no special storage conditions

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: max. length: 39 width: 2.5

Device Record Status

Public Device Record Key: 00ca710c-f940-4011-b948-bfbc9a3c2703
Public Version Date: May 08, 2025
Public Version Number: 6
DI Record Publish Date: March 15, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +49613691690
Email: info@tracoe.com

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