AccessGUDID - DEVICE: Provox Tracheofix (07331791012457)

GUDID

Device Identifier (DI) Information

Brand Name: Provox Tracheofix
Version or Model: 1 strip ivory 70x70
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1428
Company Name: Atos Medical AB

Primary DI Number: 07331791012457
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2023
Device Count: 10
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox Tracheofix is a single-use foam protector intended to absorb secretions and to provide protection and aesthetic coverage of the tracheostoma.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
63378	Tracheostoma protector, single-use	A patient-worn device in the form of a self-adhesive patch designed to protect a tracheostoma orifice against harmful external influences and to absorb secretions; it may also act as a tracheal air filter. It is typically made of porous textile, foam or synthetic fabric materials; it is not intended to be used as a shower shield. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, Wound, Hydrophilic

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: Keep dry. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Height: 70 Millimeter
Width: 70 Millimeter

Device Record Status

Public Device Record Key: fd5b3e1f-4db4-4846-87f4-c23ad29373c4
Public Version Date: July 19, 2024
Public Version Number: 3
DI Record Publish Date: July 12, 2022