Identity
- Trade Name
- Aerosol kit FDA UDI
- Generic Name
- Oxygen administration kit FDA UDI
- Device Name
- Aerosol Kit containing (1) RES019, (1) RES002, (1) RES070, (1) RES2130, (1) RES3007 FDA UDI
- Model / Reference
- APUL012AEROSOLKIT FDA UDI
- Description
- Aerosol Kit containing (1) RES019, (1) RES002, (1) RES070, (1) RES2130, (1) RES3007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00848530104931 FDA UDI
- FDA Product Code
- BZO FDA UDI
- GMDN Term
- Oxygen administration kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5975 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
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: Oxygen administration kit
Aerosol kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 96d7db61-0e1c-4328-8365-8da3ab8b4f46 34 fields · synced May 31, 2026