DEVICE: Provox® Micron HME™ (07331791001567)

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Device Identifier (DI) Information

Provox® Micron HME™
7248

Atos Medical AB
07331791001567
GS1
30
Provox Micron HME is a disposable device that features a calcium chloride-treated foam core in a plastic housing. Provox Micron HME also contains an electrostatic filter material which reduces airborne particles. The filter consists of synthetic fibres which, during the manufacturing process, generate electrical charges on the fibre surface. The result is a highly stable, coarse fibred electrostatic filter media with high efficiency against sub-micron particles and low air flow resistance.The housing of Provox Micron HME can be pressed down to occlude the stoma in order to speak with a voice prosthesis. When the pressure is released, the housing automatically retracts and opens the airway passage.
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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
Tracheostoma protective filter A non-sterile device designed as a filter for protecting a stomal opening in the windpipe (surgically-created artificial opening between the trachea and the body surface through which the patient can breathe) against harmful external influences. It may also function as a heat & moisture exchanger (HME) intended to capture the patient's exhaled breath so that it can be used to warm and moisten inspired air to help keep the trachea lubricated and prevent its mucosa from drying. It is typically designed as a hydrophobic foam filter of various sizes held in place with an adhesive strip. This is a single-use device changed regularly according to the manufacturer's instructions.
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FDA Product Code

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Product Code Product Code Name
JOH Tube Tracheostomy And Tube Cuff
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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: 07331791010590 CLOSE

Direct Marking (DM)

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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+4641519800
info@atosmedical.com
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