AccessGUDID - DEVICE: Provox Luna ShowerAid (07331791009532)

GUDID

Device Identifier (DI) Information

Brand Name: Provox Luna ShowerAid
Version or Model: 8016
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8016
Company Name: Atos Medical AB

Primary DI Number: 07331791009532
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox Luna ShowerAid is single patient use device intended to be placed into a Provox Luna Adhesive while taking a shower to protect the tracheostoma from water.

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):	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?
62047	Tracheostoma shower shield	A non-sterile, waterproof, patient-worn device intended to cover a tracheal stoma or tracheostomy tube to prevent inhalation of water during showering. It is typically in the form of a waterproof bib worn around the patient’s neck. This is a reusable device intended for single-patient use.	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
Special Storage Condition, Specify: Keep away from rain. 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
No Device Sizes

Device Record Status

Public Device Record Key: 7e82e627-ad64-497e-a443-b1dc43660de5
Public Version Date: November 25, 2024
Public Version Number: 4
DI Record Publish Date: July 12, 2022