Identity
- Trade Name
- CPAP Filter FDA UDI
- Generic Name
- CPAP/BPAP unit ambient air filter, single-use FDA UDI
- Device Name
- Philips Respironics DreamStation Style Disposable Filters in Retail Packaging 2/Pack FDA UDI
- Model / Reference
- CF1010-2RP FDA UDI
- Description
- Philips Respironics DreamStation Style Disposable Filters in Retail Packaging 2/Pack FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530086268 FDA UDI
- FDA Product Code
- JRL FDA UDI
- GMDN Term
- CPAP/BPAP unit ambient air filter, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 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
No
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
Yes
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 unit ambient air filter, single-use
CPAP Filter by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP unit ambient air filter, single-use.
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- Curaplex — BOUND TREE MEDICAL, LLC · Class II
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- ResMed AirSense 11 Style Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 51d76294-74af-43c8-badc-12a54df72594 34 fields · synced May 30, 2026