Identity
- Trade Name
- Suction Component Kit FDA UDI
- Generic Name
- Respirator filter/cartridge, particulates FDA UDI
- Device Name
- (1) RES024XL (1) BF3812 (1) RES028NS (1) RES025 FDA UDI
- Model / Reference
- RES024XL-KIT2 FDA UDI
- Description
- (1) RES024XL (1) BF3812 (1) RES028NS (1) RES025 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530104177 FDA UDI
- FDA Product Code
- CAH FDA UDI
- GMDN Term
- Respirator filter/cartridge, particulates FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5260 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: Respirator filter/cartridge, particulates
Suction Component Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 2c6de23f-5e83-43e5-87dd-016c323f2463 34 fields · synced May 30, 2026