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Summit Doppler

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
Summit Doppler FDA UDI
Generic Name
Noninvasive ankle brachial pressure index measurement unit FDA UDI
Device Name
Vista ABI - Automated ABI System: On Screen Guide, PVR, 8 MHz Doppler Probe, Auto Cuff Inflation/Deflation and 4 Cuffs FDA UDI
Model / Reference
L450VANS FDA UDI
Description
Vista ABI - Automated ABI System: On Screen Guide, PVR, 8 MHz Doppler Probe, Auto Cuff Inflation/Deflation and 4 Cuffs FDA UDI

Identifiers

Primary DI / UDI-DI
00888937002478 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

Similar devices

Also classified as Noninvasive ankle brachial pressure index measurement unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI 22e60a09-d269-44cd-bca6-ac685d766316 33 fields · synced Jun 9, 2026