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Device Explorer · FDA GUDID · GMDN 57997

Angiography contrast medium injection system, line-powered, mobile

An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for angiographic procedures (e.g., examination of the coronary and renal arteries, and great vessels and vasculature of the heart, brain, abdominal o

US‑registered devices69in commercial distribution
Companies3labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Bayer Medical Care Inc.3551%
Acist Medical Systems, Inc.3246%
Nemoto Kyorindo Co.,Ltd.23%

Top labelers

CompanyDevicesShare
Bayer Medical Care Inc.3551%
Acist Medical Systems, Inc.3246%
Nemoto Kyorindo Co.,Ltd.23%

Company = labeler of record on GUDID. 3 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PRESS DUO eliteRempressMEDRAD® Avanta Heat Maintainer, Bottle - LargeMEDRAD® Avanta Heat Maintainer, Bottle - MediumMEDRAD® Avanta Heat Maintainer, SyringeMEDRAD® Mark 7 Arterion Heat Maintainer, SyringeMEDRAD® Mark 7 Arterion Injection SystemMEDRAD® Avanta Fluid Management Injection SystemCABLE,FOOT SWITCH ASSY,UDI,BATCHASSY,CBL,STRT SW,AUX,25FT,PROV,UDI,BATCHASSY,CBL,STRT SW,AUX,85FT,PRO,UDI,BATCHASSY,CBL,STRT SW,AUX,60FT,PROV,UDI,BATCHASSY,CBL,STRT SW,REMOTE,PROVIS,UDI,BATCHACIST CVi® Contrast Delivery SystemCVi® CableCVi® Accessory

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

FDA product codes

CodeNameDevices
DXTInjector And Syringe, Angiographic98
DXTInjector and syringe, angiographic2

GMDN & GCC registration

  • GMDN code 57997 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 100% · 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

No structured size data on the register.

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

How many angiography contrast medium injection system, line-powered, mobile products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Angiography contrast medium injection system, line-powered, mobile", from 3 companies. The largest labeler is Bayer Medical Care Inc. with 51% of records.

Which FDA product codes apply?

DXT (Injector And Syringe, Angiographic), DXT (Injector and syringe, angiographic)

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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