Summit Doppler

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name: Summit Doppler FDA UDI
Generic Name: Noninvasive vascular ultrasound system FDA UDI
Device Name: Vantage ABI System Contents: Two 10 cm cuffs, two 12cm cuffs, four color-coded hoses, reporting software CD and USB memory stick. FDA UDI
Model / Reference: VANABI FDA UDI
Description: Vantage ABI System Contents: Two 10 cm cuffs, two 12cm cuffs, four color-coded hoses, reporting software CD and USB memory stick. FDA UDI

Identifiers

Primary DI / UDI-DI: 00888937011357 FDA UDI
510(k) Number: K103693 FDA UDI
FDA Product Code: DXN FDA UDI
GMDN Term: Noninvasive vascular ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1130 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Noninvasive vascular ultrasound system

Summit Doppler by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Noninvasive vascular ultrasound system.

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Vave — VAVE HEALTH INC · Class II
DigiDop — Newman Medical · Class II
DigiDop — Newman Medical · Class II
A.M.I. HAL Handle — AMI Agency for Medical Innovations GmbH · Class II
SMARTNEEDLE — TELEFLEX INCORPORATED · Class II
McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II

Cleared under the same submission

K103693 also covers:

Summit Doppler — CooperSurgical, Inc.

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 06cb8a2b-5186-4b4d-ba1d-b5f55ea98f2d 34 fields · synced Jun 9, 2026