DEVICE: Provox® FreeHands HME® Speech Valve Membrane Light (07331791002915)

Device Identifier (DI) Information

Provox® FreeHands HME® Speech Valve Membrane Light
Light
Not in Commercial Distribution
7713
Atos Medical AB
07331791002915
GS1
December 31, 2016
1
355470923 *Terms of Use
The Membrane temporarily closes the Freehands HME Speech Valve, allowing the patient to produce voice without manually occluding the stoma.
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Device Characteristics

MR Unsafe
No
No
Yes
No
Yes
Yes
Yes
No

GMDN

[?]

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.
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FDA Product Code

[?]
Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K022125 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

fd5ec837-9f9d-4ed3-8b3c-24f55fa57a9b
August 23, 2018
4
September 11, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4641519800
info@atosmedical.com
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