Identity
- Trade Name
- Summit Doppler FDA UDI
- Generic Name
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
- Device Name
- Vista AVS - Advanced ABI/Vascular System: On Screen Guide, PVR, 8.0 MHz Doppler probe, PPG, Auto Cuff Inflation/Deflation, Individual Site Mode, PC Software, Stand and 9 Cuffs FDA UDI
- Model / Reference
- L500VA FDA UDI
- Description
- Vista AVS - Advanced ABI/Vascular System: On Screen Guide, PVR, 8.0 MHz Doppler probe, PPG, Auto Cuff Inflation/Deflation, Individual Site Mode, PC Software, Stand and 9 Cuffs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00888937002485 FDA UDI
- FDA Product Code
- HEK FDA UDI
- GMDN Term
- Noninvasive ankle brachial pressure index measurement unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.2660 FDA UDI
- Commercial Distribution
- 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Noninvasive ankle brachial pressure index measurement unit
Summit Doppler by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- CooperSurgical, Inc.
Sources (1)
- FDA UDI 152f350a-c53a-4940-9df7-9befe4b2e3be 33 fields · synced Jun 9, 2026