Identity
- Trade Name
- Combo Pack FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Combo pack of Covidien Nellcor Puritan Bennett GoodKnight 420/425 Style, 1 Foam and 2 Ultrafine Filters. FDA UDI
- Model / Reference
- CF6003Combo FDA UDI
- Description
- Combo pack of Covidien Nellcor Puritan Bennett GoodKnight 420/425 Style, 1 Foam and 2 Ultrafine Filters. FDA UDI
Identifiers
- Catalog Number
- CF6003Combo FDA UDI
- Primary DI / UDI-DI
- 00848530034436 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP nasal mask, reusable
Combo Pack by SUNSET HEALTHCARE SOLUTIONS, 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
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
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 8a819e89-30c8-464e-8183-f24af58c3fd2 35 fields · synced Jun 1, 2026