DEVICE: Respire Pink EF+ with DentiTrac (00851861007246)
Device Identifier (DI) Information
Respire Pink EF+ with DentiTrac
SPPD030US
Not in Commercial Distribution
RESPIRE MEDICAL HOLDINGS LLC
SPPD030US
Not in Commercial Distribution
RESPIRE MEDICAL HOLDINGS LLC
Intraoral appliance for the treatment of snoring and mild to moderate obstructive sleep apnea with patient monitoring.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
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 |
---|---|
PLC | Sleep Appliances With Patient Monitoring |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K170692 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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Circumference: 200 Millimeter |
Device Record Status
a7da70a9-0c5c-4c0a-84a0-df6a9ff8d506
February 17, 2020
6
September 15, 2017
February 17, 2020
6
September 15, 2017
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
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
7186437326
info@respiremedical.com
info@respiremedical.com