DEVICE: Provox® FreeHands HME® Moist (07331791008368)

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Device Identifier (DI) Information
Provox® FreeHands HME® Moist
Moist
8220
Atos Medical AB
07331791008368
GS1
30
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.
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Device Characteristics
MR Safe
No
No
Yes
Yes
No
No
No
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 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

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Product Code Product Code Name
EWL Prosthesis, Laryngeal (Taub)
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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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.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status
In Commercial Distribution
September 11, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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: 07331791010613 CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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+4641519800
info@atosmedical.com
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