Identity
- Trade Name
- Nasal Interface, 3Pk FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Nasal Interface 3Pk, RP-1000 FDA UDI
- Model / Reference
- RP-1000 FDA UDI
- Description
- Nasal Interface 3Pk, RP-1000 FDA UDI
Identifiers
- Catalog Number
- RP-1000 FDA UDI
- Primary DI / UDI-DI
- 00817131020315 FDA UDI
- 510(k) Number
- K152664 FDA UDI
- FDA Product Code
- ONZ FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CPAP/BPAP nasal mask, reusable
Nasal Interface, 3Pk by Inogen, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP nasal mask, reusable.
- DreamWear — Respironics, Inc. · Class II
- SWIFT FX — RESMED PTY LTD · Class II
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- Nasal-Aire — Innomed Technologies · Class II
- ComfortGel Blue — Respironics, Inc. · Class II
- Dream Wisp — Respironics, Inc. · Class II
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- DreamWear Gel Pillow — Respironics, Inc. · Class II
Cleared under the same submission
K152664 also covers:
- 1160 AIR DISS Regulator TAV — Inogen, Inc.
- 1240 O2 DISS Regulator TAV — Inogen, Inc.
- 25ft O2 Delivery Tube TAV, 1PK — Inogen, Inc.
- 50ft O2 Delivery Tube TAV, 1PK — Inogen, Inc.
- 7ft O2 Delivery Tube TAV, 1PK — Inogen, Inc.
- Inogen Tidal Assist Ventilator Controller — Inogen, Inc.
- Inogen Tidal Assist Ventilator System — Inogen, Inc.
- Nasal Interface, 1PK — Inogen, Inc.
- TAV 25ft O2 Delivery Tubing — Inogen, Inc.
- TAV 50ft O2 Delivery Tubing — Inogen, Inc.
- TAV 7ft O2 Delivery Tubing — Inogen, Inc.
- TAV Nasal Interface — Inogen, Inc.
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
- Inogen, Inc.
Sources (1)
- FDA UDI 34e497db-e2b4-44a5-bc46-91febd37061f 36 fields · synced Jun 8, 2026