AccessGUDID - DEVICE: TrachPhone (30 pcs) (07331791009693)

GUDID

Device Identifier (DI) Information

Brand Name: TrachPhone (30 pcs)
Version or Model: 7707
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7707
Company Name: Atos Medical AB

Primary DI Number: 07331791009693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: For patients breathing spontaneously via an ET tube or a tracheostomy tube in the hospital or at home.

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?
58705	Tracheostoma protective filter	A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BYD	Condenser, Heat And Moisture (Artificial Nose)

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
Storage Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep away from rain. Keep away from sunlight.
Storage Environment Temperature: between 2 and 42 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 826d7e92-dd8a-48ec-844e-f08d6fda988f
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: November 29, 2022