Identity
- Trade Name
- Oxygen Kit FDA UDI
- Generic Name
- Respirator filter/cartridge, particulates FDA UDI
- Device Name
- EverFlo kit - BF1001 (1), BF316-1 (1) FDA UDI
- Model / Reference
- APAR008EVERFLOKITA FDA UDI
- Description
- EverFlo kit - BF1001 (1), BF316-1 (1) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530083861 FDA UDI
- GMDN Term
- Respirator filter/cartridge, particulates FDA UDI
Classification
- 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
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: Respirator filter/cartridge, particulates
Oxygen Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Respirator filter/cartridge, particulates.
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- Bacteria Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- Bacteria Filter — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
- CPAP Filter — SUNSET HEALTHCARE SOLUTIONS, 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 9c60bab8-3cbb-4ab2-8a86-87268a540b11 34 fields · synced May 29, 2026