DEVICE: Apnea Guard (00850015266461)
Device Identifier (DI) Information
Apnea Guard
AG25-1009(UK)
In Commercial Distribution
ADVANCED BRAIN MONITORING, INC.
AG25-1009(UK)
In Commercial Distribution
ADVANCED BRAIN MONITORING, INC.
Apnea Guard Starter Kit 1L3M1H UK
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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LRK | Device, Anti-Snoring |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K111110 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 4 and 25 Degrees Celsius |
Storage Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Handling Environment Humidity: between 15 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
9c83cb12-401d-49da-a451-a3ea9f64107e
March 15, 2022
1
March 07, 2022
March 15, 2022
1
March 07, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined