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Device Explorer · FDA GUDID · GMDN 58000

CT contrast medium injection system, line-powered, stationary

An assembly of devices designed to inject contrast media through a small catheter and into the vascular system for computed tomography (CT) procedures (e.g., spine, head, gastrointestinal, or vascular diagnostic procedures using CT scanning). It consists of ma

US‑registered devices53in commercial distribution
Companies2labelers on GUDID
Single‑use0%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Bracco Injeneering Sa4483%
Liebel-Flarsheim Company Llc917%

Top labelers

CompanyDevicesShare
Bracco Injeneering Sa4483%
Liebel-Flarsheim Company Llc917%

Company = labeler of record on GUDID. 2 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

EmpowerCTA+ Injector SystemEmpowerCTA®+ Injector System 1731 ed03EmpowerCTA®+ Injector SystemCT Expres™ 3DFloor StandIV PoleInjector Mounting Arm, RightInjector Mounting Arm, LeftEDA ClipFloor Stand ShroudCeiling Column ShortCeiling Column MediumCeiling Column LongCeiling Mount Adapter PlateArticulating armIV pole

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

FDA product codes

CodeNameDevices
IZQInjector, Contrast Medium, Automatic70
JAKSystem, X-Ray, Tomography, Computed51
DSBPlethysmograph, Impedance40
DXTInjector And Syringe, Angiographic1

GMDN & GCC registration

  • GMDN code 58000 · non‑implantable
  • Single‑use 0% · sterile 0% · Rx‑only 94% · 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

Length (Feet) · 1Length (Meter) · 1

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

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

53 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "CT contrast medium injection system, line-powered, stationary", from 2 companies. The largest labeler is Bracco Injeneering Sa with 83% of records.

Which FDA product codes apply?

IZQ (Injector, Contrast Medium, Automatic), JAK (System, X-Ray, Tomography, Computed), DSB (Plethysmograph, Impedance), 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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