DEVICE: Provox® FreeHands HME® Replacement Device (07331791003004)

Device Identifier (DI) Information

Provox® FreeHands HME® Replacement Device
7722
Not in Commercial Distribution

Atos Medical AB
07331791003004
GS1
December 31, 2016
1
355470923 *Terms of Use
PROVOX® FreeHands HME is an automatic, reusable multi-magnet valve system that keeps the valve closed during speech.
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Device Characteristics

MR Unsafe
No
No
Yes
Yes
No
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 that is attached to a tracheostomy tube and is designed to eliminate the necessity of finger occlusion, enabling the tracheostomized patient to speak easily and more clearly. It can be made of metal [e.g., silver (Ag)] or plastic. This is a reusable device.
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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 [?]
Premarket Submission Number Not Available/Not Released
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

4b9a061d-331f-4484-9065-b44f0e7f8128
March 29, 2018
2
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

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

[?]
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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