Identity
- Trade Name
- Portable Mesh Nebulizer FDA UDI
- Generic Name
- Nebulizing system delivery set, reusable FDA UDI
- Model / Reference
- Air Pro VIII FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934325338705 FDA UDI
- 510(k) Number
- K182906 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Nebulizing system delivery set, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5630 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Portable Mesh Nebulizer by Feellife Health Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K182906 also covers:
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC.
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC.
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC.
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC.
- Portable Mesh Nebulizer — FEELLIFE HEALTH INC.
- Handheld Compressor Nebulizer — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Nebulizer Kit — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Sunset Handheld Mesh Nebulizer — SUNSET HEALTHCARE SOLUTIONS, Inc.
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
- Feellife Health Inc.
Sources (1)
- FDA UDI c6b86c44-e514-4d77-81b5-eb9d4edae35a 34 fields · synced Jun 1, 2026