Identity
- Trade Name
- FLO-001 FLOtector Ultrasonic Blood Flow Detector FDA UDI
- Generic Name
- Vascular ultrasound system control unit FDA UDI
- Device Name
- 128170 FLO-FLOTECTOR Edwards Doppler Transceiver FDA UDI
- Model / Reference
- 128170 FDA UDI
- Description
- 128170 FLO-FLOTECTOR Edwards Doppler Transceiver FDA UDI
Identifiers
- Catalog Number
- 128170 FDA UDI
- Primary DI / UDI-DI
- 00817122020454 FDA UDI
- 510(k) Number
- K082870 FDA UDI
- FDA Product Code
- DPW FDA UDI
- GMDN Term
- Vascular ultrasound system control unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2100 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
FLO-001 FLOtector Ultrasonic Blood Flow Detector by Vascular Technology Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K082870 also covers:
- 07-150-02 20 MHz Mizuho Surgical Doppler Transceiver — VASCULAR TECHNOLOGY INCORPORATED
- 07-150-08 Mizuho Doppler 8 MHz Dual Channel, AC Power — VASCULAR TECHNOLOGY INCORPORATED
- 07-150-20 Mizuho 20 MHz Surgical Doppler Transceiver, AC — VASCULAR TECHNOLOGY INCORPORATED
- 8 MHz Kelly Endonasal Disposable Doppler Probe, Box — VASCULAR TECHNOLOGY INCORPORATED
- Footswitch, Mute, for Use with VTI TQI Doppler Gen 0.5 — VASCULAR TECHNOLOGY INCORPORATED
- GEM IntraOp Doppler, Hand-Held Dopplers — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 07-150-07 Disposable Doppler Probe for Neurosurgery, Box — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 07-150-10 Disposable Doppler Probe for Neurosurgery, Box — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 07-150-12 20 MHz Micro Disposable Doppler Probe, Box — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 07-150-21 20 MHz Disposable Doppler Probe Straight, Box — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 07-150-22 20 MHz Disposable Doppler Probe Curved Tip, Box — VASCULAR TECHNOLOGY INCORPORATED
- Mizuho 20 MHz Micro Disposable Doppler Probe, Box — VASCULAR TECHNOLOGY INCORPORATED
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vascular Technology Incorporated
Sources (1)
- FDA UDI 102917a0-4b55-44c1-8084-275d3b13970d 38 fields · synced Jun 1, 2026