Identity
- Trade Name
- Provent Sleep Therapy FDA UDI
- Generic Name
- Nasal dilator FDA UDI
- Device Name
- Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices FDA UDI
- Model / Reference
- CAT1114 FDA UDI
- Description
- Provent 30 Night Starter Kit contains two (2) Light resistance (Phase 1) non-therapeutic acclimation units, two (2) Medium resistance (Phase 2) non-therapeutic acclimation units, and 26 Standard resistance Provent devices FDA UDI
Identifiers
- Catalog Number
- CAT1114 FDA UDI
- Primary DI / UDI-DI
- 00868020000215 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
Similar devices
Also classified as Nasal dilator.
- Bioseal Inc. — BIOSEAL · Class I
- Bongo Rx — AirAvant Medical · Class II
- Bongo Rx — AirAvant Medical · Class II
- Bongo Rx — AirAvant Medical · Class II
- Bongo Rx — AirAvant Medical · Class II
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- RZ Medizintechnik GmbH — RZ-Medizintechnik GmbH · Class I
- Bongo Rx — AirAvant Medical · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Provent Sleep Therapy, Llc
Sources (1)
- FDA UDI 594a75db-e428-4416-a58e-8e350c20f18a 38 fields · synced May 30, 2026