DEVICE: Provox® ActiValve® Lubricant (07331791000515)

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Device Identifier (DI) Information

Provox® ActiValve® Lubricant
7149

Atos Medical AB
07331791000515
GS1
1
Provox ActiValve Lubricant shall be applied as a thin film on the inner lumen of Provox ActiValve voice prosthesis to help prevent occasional temporary blockage of the valve.
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Device Characteristics

MR Unsafe
No
No
Yes
No
Yes
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Tracheoesophageal speech valve, indwelling, non-sterile A non-sterile device designed to be inserted into a surgically-created tracheoesophageal fistula after total laryngectomy to provide the patient with voice restoration. It is inserted and replaced as needed by a medical professional. It has a double flange (one on the outside of the throat and one on the inside) to hold it in place and includes a one-way valve that protects the airway during swallowing and opens under positive pressure so that air crosses into the oesophagus to produce voice (speech rehabilitation). It is routinely cleaned by the user in situ and assistive cleaning devices (e.g., brush) may be included. This is a single-use 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: 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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