Identity
- Trade Name
- Provent Sleep Therapy FDA UDI
- Generic Name
- Nasal dilator FDA UDI
- Device Name
- Provent 30 Night Standard Pack contains 30 Standard resistance Provent FDA UDI
- Model / Reference
- CAT1105 FDA UDI
- Description
- Provent 30 Night Standard Pack contains 30 Standard resistance Provent FDA UDI
Identifiers
- Catalog Number
- CAT1105 FDA UDI
- Primary DI / UDI-DI
- 00868020000208 FDA UDI
- 510(k) Number
- K102404 FDA UDI
- FDA Product Code
- OHP FDA UDI
- GMDN Term
- Nasal dilator 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Nasal dilator
Provent Sleep Therapy by Provent Sleep Therapy, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102404 also covers:
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
- Provent Sleep Therapy, Llc
Sources (1)
- FDA UDI 1174e15c-8b26-47db-b8e8-465bb831697a 38 fields · synced May 31, 2026