AccessGUDID - DEVICE: Provox® FreeHands HME® Casette (07331791005022)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® FreeHands HME® Casette
Version or Model: 7711
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Atos Medical AB

Primary DI Number: 07331791005022
Issuing Agency: GS1
Commercial Distribution End Date: June 13, 2023
Device Count: 30
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: The Freehands HME Cassette heats and humidifies the inhaled air and partially restores breathing resistance. The FreeHands HME Cassette should only be used with the Provox Freehands automatic speech valve.

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):	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?
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
EWL	Prosthesis, Laryngeal (Taub)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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 dry. Keep away from sunlight.
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b29dcf84-a7b0-4763-ad4f-a0815285788f
Public Version Date: June 14, 2023
Public Version Number: 4
DI Record Publish Date: September 11, 2016