Identity
- Trade Name
- Vensure Inflation Device FDA UDI
- Generic Name
- Nasal/paranasal balloon catheter FDA UDI
- Device Name
- Inflation device for Vensure Balloon Dilation System FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Inflation device for Vensure Balloon Dilation System FDA UDI
Identifiers
- Catalog Number
- E 01 3592 FDA UDI
- Primary DI / UDI-DI
- EFIAE0135921 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Nasal/paranasal balloon catheter FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Vensure Inflation Device by Fiagon GmbH — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Fiagon GmbH
Sources (1)
- FDA UDI 55aa96e9-1172-42f2-bd1d-f6d2385a67c8 35 fields · synced May 31, 2026