Identity
- Trade Name
- Plastic Intake Nebulizer Filter - with Head FDA UDI
- Generic Name
- Suction system filter, microbial FDA UDI
- Device Name
- Sunset Healthcare Solutions Plastic Intake Nebulizer Filter - with Head FDA UDI
- Model / Reference
- BF016-1 FDA UDI
- Description
- Sunset Healthcare Solutions Plastic Intake Nebulizer Filter - with Head FDA UDI
Identifiers
- Catalog Number
- BF016-1 FDA UDI
- Primary DI / UDI-DI
- 00848530010119 FDA UDI
- FDA Product Code
- JRL FDA UDI
- GMDN Term
- Suction system filter, microbial 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
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
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: Suction system filter, microbial
Plastic Intake Nebulizer Filter - with Head by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suction system filter, microbial.
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- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Roscoe Medical — COMPASS HEALTH BRANDS CORP. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 6c94ab29-3f10-4f50-9f36-7eea622cc241 36 fields · synced Jun 8, 2026