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Device Explorer · FDA GUDID · GMDN 47258

Contrast medium injection system administration set

A collection of noninvasive devices designed to conduct fluids between a contrast medium injection system and a patient catheter for the delivery of a contrast medium and/or saline solution to a patient undergoing a diagnostic imaging procedure. It consists of

US‑registered devices2,327in commercial distribution
Companies7labelers on GUDID
Single‑use100%of device records
Sterile100%labelled sterile
Prescription44%Rx‑only share
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Share of device records

Merit Medical Systems, Inc.2,31199%
Ulrich Gmbh & Co. Kg50%
Valflux Group, Llc30%
Medline Industries, Inc.30%
Argon Critical Care Systems Singapore Pte. Ltd.20%
Acist Medical Systems, Inc.20%
Icu Medical, Inc.10%

Top labelers

CompanyDevicesShare
Merit Medical Systems, Inc.2,31199%
Ulrich Gmbh & Co. Kg50%
Valflux Group, Llc30%
Medline Industries, Inc.30%
Argon Critical Care Systems Singapore Pte. Ltd.20%
Acist Medical Systems, Inc.20%
Icu Medical, Inc.10%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

ulrich medical disposablesMerit Medical®KyphoFlex™MANIFOLDICU MedicalNAMICCritikit™ACIST VeraPro AMT Auto-Manifold and TransducerBT2000 Automated Manifold Kit

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

FDA product codes

CodeNameDevices
OEZCardiovascular procedure kit2,300
DXTInjector And Syringe, Angiographic16
OEQAngiography/angioplasty kit6
IZQInjector, Contrast Medium, Automatic5
DQOCatheter, intravascular, diagnostic4
DTLAdaptor, stopcock, manifold, fitting, cardiopulmonary bypass3

GMDN & GCC registration

  • GMDN code 47258 · non‑implantable
  • Single‑use 100% · sterile 100% · Rx‑only 44% · 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.

No closely related category with 50+ devices.

How many contrast medium injection system administration set products are registered in the US?

2,327 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Contrast medium injection system administration set", from 7 companies. The largest labeler is Merit Medical Systems, Inc. with 99% of records.

Which FDA product codes apply?

OEZ (Cardiovascular procedure kit), DXT (Injector And Syringe, Angiographic), OEQ (Angiography/angioplasty kit), IZQ (Injector, Contrast Medium, Automatic)

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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