Consulting Wallah › Device Explorer › Cardiovascular › Noninvasive vascular ultrasound system
Device Explorer · FDA GUDID · GMDN 44311

Noninvasive vascular ultrasound system

An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical d

US‑registered devices144in commercial distribution
Companies10labelers on GUDID
Single‑use3%of device records
Sterile3%labelled sterile
Prescription97%Rx‑only share
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Share of device records

Coopersurgical, Inc.8559%
Newman Medical Llc2819%
Huntleigh Healthcare Limited107%
Teleflex Incorporated53%
D.E.Hokanson, Inc.43%
Mckesson Medical-Surgical Inc.43%
Ami Agency For Medical Innovations Gmbh32%
Koven Technology, Inc.32%

Top labelers

CompanyDevicesShare
Coopersurgical, Inc.8559%
Newman Medical Llc2819%
Huntleigh Healthcare Limited107%
Teleflex Incorporated53%
D.E.Hokanson, Inc.43%
Mckesson Medical-Surgical Inc.43%
Ami Agency For Medical Innovations Gmbh32%
Koven Technology, Inc.32%
Transonic Systems Inc.11%
Novasignal Corp.11%

Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DOPPLEXWi-3 ArmRAR Flexi ProbeA.M.I. HAL HandlePG-21BiDop 7BiDop 3LifeDop® 250 ABI system with 2 cuffs, aneroid anTRIA® II Display Doppler with 8.0 MHz SterilizabSummit DopplerMediChoiceMedi ChoiceMedaSonicsClearToneClearTone DopplerTRIA II Doppler

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
HEPMonitor, Blood-Flow, Ultrasonic60
JAFMonitor, Ultrasonic, Nonfetal37
ITXTransducer, Ultrasonic, Diagnostic18
KNGMonitor, Ultrasonic, Fetal11
DPWFlowmeter, Blood, Cardiovascular8
MAAMonitor, Fetal Doppler Ultrasound8

GMDN & GCC registration

  • GMDN code 44311 · non‑implantable
  • Single‑use 3% · sterile 3% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Needle Gauge (Gauge) · 11Height (Centimeter) · 1Outer Diameter (Centimeter) · 1Length (Millimeter) · 1Outer Diameter (Millimeter) · 1Weight (Kilogram) · 1

Use these as the dimensions to specify in a tender line.

How many noninvasive vascular ultrasound system products are registered in the US?

144 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Noninvasive vascular ultrasound system", from 10 companies. The largest labeler is Coopersurgical, Inc. with 59% of records.

Which FDA product codes apply?

HEP (Monitor, Blood-Flow, Ultrasonic), JAF (Monitor, Ultrasonic, Nonfetal), ITX (Transducer, Ultrasonic, Diagnostic), KNG (Monitor, Ultrasonic, Fetal)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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