AccessGUDID - DEVICE: Provox® Micron HME™ (07331791001550)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® Micron HME™
Version or Model: 7247
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Atos Medical AB

Primary DI Number: 07331791001550
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.

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
JOH	Tube Tracheostomy And Tube Cuff

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K072582	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 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: ebbcecd4-c29c-41af-b37f-1ef58f268745
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 11, 2016