Identity
- Trade Name
- PureSleep FDA UDI
- Generic Name
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
- Device Name
- One PureSleep Anti-Snoring Mouthpiece Kit US FDA UDI
- Model / Reference
- PSKITA2ES FDA UDI
- Description
- One PureSleep Anti-Snoring Mouthpiece Kit US FDA UDI
Identifiers
- Catalog Number
- PSKITA2ES FDA UDI
- Primary DI / UDI-DI
- 00851727004020 FDA UDI
- 510(k) Number
- K954128 FDA UDI
- FDA Product Code
- LRK FDA UDI
- GMDN Term
- Mandible-repositioning sleep-disordered breathing orthosis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.5570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Mandible-repositioning sleep-disordered breathing orthosis
PureSleep by Sleep Science Partners, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sleep Science Partners, Inc.
Sources (1)
- FDA UDI 6175c041-8234-42cd-8fb2-6f55f8f8f9b4 35 fields · synced May 30, 2026