Identity
- Trade Name
- Fluent™ inflation device FDA UDI
- Generic Name
- Catheter/overtube balloon inflator, single-use FDA UDI
- Device Name
- The Fluent inflation device kit and components are to be used to facilitate the use of guidewires, catheters, balloons, and other interventional devices during angioplasty procedures. Model 8259 contains Fluent inflation device, stopcock, guidewire introducer, hemostasis valve, torque device and 50 cm extension tube. FDA UDI
- Model / Reference
- 8259 FDA UDI
- Description
- The Fluent inflation device kit and components are to be used to facilitate the use of guidewires, catheters, balloons, and other interventional devices during angioplasty procedures. Model 8259 contains Fluent inflation device, stopcock, guidewire introducer, hemostasis valve, torque device and 50 cm extension tube. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M20682590 FDA UDI
- FDA Product Code
- MAV FDA UDI
- GMDN Term
- Catheter/overtube balloon inflator, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1650 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
Yes
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Fluent™ inflation device by Vascular Solutions, Inc. — 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
- Vascular Solutions, Inc.
Sources (1)
- FDA UDI 411279d0-d6c6-407e-85a3-7700442ffde5 35 fields · synced May 30, 2026