Consulting Wallah › Device Explorer › Other devices › External ventricular circulatory assist system
Device Explorer · FDA GUDID · GMDN 10847

External ventricular circulatory assist system

An assembly of devices intended to assist a damaged or weakened heart (e.g., one affected by cardiogenic shock) to pump blood. It includes a electrically-powered external pump, an atrial or ventricular cannula to draw blood outside the body, a cannula to deliv

US‑registered devices55in commercial distribution
Companies4labelers on GUDID
Single‑use93%of device records
Sterile78%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Berlin Heart Gmbh4276%
Novo Surgical, Inc.916%
Thoratec Corporation35%
Thoratec Switzerland Gmbh12%

Top labelers

CompanyDevicesShare
Berlin Heart Gmbh4276%
Novo Surgical, Inc.916%
Thoratec Corporation35%
Thoratec Switzerland Gmbh12%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EXCOR®Novo Surgical Inc.THORATEC® PVAD™, ATRIAL CANNULA - SHORT, BEVELEDTHORATEC® PVAD™, ATRIAL CANNULA - LONG, BEVELED THORATEC® PVAD™, VENTRICULAR ASSIST DEVICE - BLONovo SurgicalCENTRIMAG RVAS HDE KIT

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

FDA product codes

CodeNameDevices
DSQVentricular (Assisst) Bypass45
HCDCannula, Ventricular9
OJERight Ventricular Bypass (Assist) Device1

GMDN & GCC registration

  • GMDN code 10847 · non‑implantable
  • Single‑use 93% · sterile 78% · Rx‑only 96% · 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

Lumen/Inner Diameter (Millimeter) · 32Total Volume (Milliliter) · 6

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

How many external ventricular circulatory assist system products are registered in the US?

55 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "External ventricular circulatory assist system", from 4 companies. The largest labeler is Berlin Heart Gmbh with 76% of records.

Which FDA product codes apply?

DSQ (Ventricular (Assisst) Bypass), HCD (Cannula, Ventricular), OJE (Right Ventricular Bypass (Assist) Device)

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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