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Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit FDA UDI
- Generic Name
- Therapeutic agent nebulizer, benchtop FDA UDI
- Device Name
- Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit FDA UDI
- Model / Reference
- NEB100-R FDA UDI
- Description
- Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit FDA UDI
Identifiers
- Catalog Number
- NEB100-R FDA UDI
- Primary DI / UDI-DI
- 00848530089146 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Therapeutic agent nebulizer, benchtop FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Therapeutic agent nebulizer, benchtop
Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID
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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 9dd086bc-9cfb-44b7-aec9-946f5d0f8082 35 fields · synced May 30, 2026