Identity
- Trade Name
- 525 DS Kit FDA UDI
- Generic Name
- CPAP/BPAP unit ambient air filter, reusable FDA UDI
- Device Name
- This kit contains: 2 OF5004 Foam Cabinet Filters, 1 OF6011 Extended Life Bacteria Filter w/ Muffler, 1 BF1438 Final Bacteria Filter. FDA UDI
- Model / Reference
- OF5004DS FDA UDI
- Description
- This kit contains: 2 OF5004 Foam Cabinet Filters, 1 OF6011 Extended Life Bacteria Filter w/ Muffler, 1 BF1438 Final Bacteria Filter. FDA UDI
Identifiers
- Catalog Number
- OF5004DS FDA UDI
- Primary DI / UDI-DI
- 00848530086411 FDA UDI
- GMDN Term
- CPAP/BPAP unit ambient air filter, reusable FDA UDI
Classification
- 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
No
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
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, reusable
525 DS Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP unit ambient air filter, reusable.
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Invacare Polaris LT Style Ultrafine Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Breas PV1 Style Ultrafine Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Covidien Nellcor Puritan Bennett Sandman Style Foam Filters — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- CPAP Filter — 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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI d68ee517-f1f1-4d8a-972f-4480a49502ce 35 fields · synced May 30, 2026