DEVICE: ApneaRx (00861481000329)

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Device Identifier (DI) Information

ApneaRx
Small

APNEA SCIENCES CORPORATION
00861481000329
GS1
1
Small Mouth Guard
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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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
Mandible-repositioning antisnoring orthosis A removable intraoral device designed to prevent snoring and/or obstructive sleep apnoea by repositioning the lower jaw (mandible), frequently in a downward and forward position. It works by locking the mandible (e.g., holding the teeth) and preventing it from retruding, thus increasing the patency of the airway and decreasing both air turbulence and airway obstruction. The device is typically made of soft and/or hard materials (e.g., plastics and metals); it may or may not be available [non-prescription] over-the-counter (OTC). A number of different fixed (non-adjustable) and adjustable types using several techniques are available. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
LRK Device, Anti-Snoring
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Sterilization

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Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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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
November 15, 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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