AccessGUDID - DEVICE: TRACOE comfort (04035324014491)

GUDID

Device Identifier (DI) Information

Brand Name: TRACOE comfort
Version or Model: REF 204-07A-O
Commercial Distribution Status: In Commercial Distribution
Catalog Number: REF 204-07A-O
Company Name: Tracoe medical GmbH

Primary DI Number: 04035324014491
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 319414785 *Terms of Use

Device Description: Extra-Long Tube, Fenestrated, with Swivel Speaking Valve, Type B, with additional Inner cannula with 15 mm Connector, with additional oxygen supply port

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":	Yes
For Single-Use:	No
Prescription Use (Rx):	Yes
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?
38792	Tracheostomy tube, non-reinforced, non-customized, reusable	A hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTO	Tube, tracheostomy (w/wo connector)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K781729	000

Device Exempt from Premarket Submission: No 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: Keep away from rain. Keep away from sunlight. Do not resterilize.

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 6.0 Millimeter

Device Record Status

Public Device Record Key: 6b82ea18-1e1f-4d63-a77b-3b5a556e0e62
Public Version Date: November 29, 2024
Public Version Number: 6
DI Record Publish Date: July 03, 2017