Identity
- Trade Name
- FLYp FDA UDI
- Generic Name
- Ultrasonic nebulizing system FDA UDI
- Device Name
- Vibrating mesh nebulizer FDA UDI
- Model / Reference
- 0001 FDA UDI
- Description
- Vibrating mesh nebulizer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00869112000106 FDA UDI
- FDA Product Code
- CAF FDA UDI
- GMDN Term
- Ultrasonic nebulizing system 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
FLYp by Convexity Scientific, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Convexity Scientific, LLC
Sources (1)
- FDA UDI 5725f995-f88e-42b5-87cf-0f35bb0521f0 36 fields · synced May 30, 2026