DEVICE: SnoreMD (00861481000305)

Device Identifier (DI) Information

SnoreMD
1
In Commercial Distribution

APNEA SCIENCES CORPORATION
00861481000305
GS1

1
070448734 *Terms of Use
Mouth Guard
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
47526 Mandible-repositioning sleep-disordered breathing orthosis
A removable intraoral device designed to alleviate sleep-disordered breathing conditions (e.g., snoring, obstructive sleep apnoea) by repositioning and/or controlling the lower jaw (mandible), typically 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. A number of different fixed (non-adjustable) and adjustable types using several techniques and materials are available. This is a reusable device.
Active false
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FDA Product Code

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Product Code Product Code Name
LRK Device, Anti-Snoring
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K112205 000
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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
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 Record Status

4365e609-2d1a-4f65-a9f9-802fdd8f079d
July 06, 2018
3
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
No
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Customer Contact

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No Customer Contact currently defined
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