AccessGUDID - DEVICE: Provox® FreeHands HME® Moist (07331791008368)

GUDID

Device Identifier (DI) Information

Brand Name: Provox® FreeHands HME® Moist
Version or Model: Moist
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8220
Company Name: Atos Medical AB

Primary DI Number: 07331791008368
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 355470923 *Terms of Use

Device Description: Provox ® FreeHands HME Moist / Flow are designed to allow automatic tracheostoma closure for voice prosthesis users while providing heat and moisture exchange for pulmonary rehabilitation.

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Tracheostomy tube speech valve	A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

GMDN Preferred Term Name

GMDN Definition

Tracheostomy tube speech valve

A device designed to be attached to a tracheostomy tube to eliminate the necessity of finger occlusion during speech, enabling the tracheostomized patient to speak easily and more clearly. It is typically intended to be regularly attached and removed by the patient (e.g., before and after sleeping). It may be made of metal [e.g., silver (Ag)] or plastic materials, and some types may have a sideport for connection to an oxygen supply. This is a single-patient device that may be reapplied over a period of time before being discarded.

FDA Product Code

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Product Code	Product Code Name
EWL	Prosthesis, Laryngeal (Taub)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141380	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

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Storage and Handling
Handling Environment Temperature: between 36 and 108 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry. Keep away from sunlight.

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cb6193cd-9c89-4693-bb02-677f57ce8085
Public Version Date: August 23, 2018
Public Version Number: 4
DI Record Publish Date: September 11, 2016