FDA.reportPublic FDA data

ulrichINJECT CT motion

Primary DI
04052536230495
Brand
ulrichINJECT CT motion
Company
Ulrich GmbH & Co. KG
Model
XD 8000
Catalog number
XD 8000
Device description
ulrichINJECT CT motion
Published
2025-12-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
IZQInjector, Contrast Medium, Automatic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZQInjector, Contrast Medium, AutomaticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251295000ulrichINJECT CT Motion (XD 8000)Ulrich GmbH & Co. KG2025-11-07IZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536230495PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536230495040525362304954052536230495

GMDN Terms#

Term, Definition table
TermDefinition
CT contrast medium injection system, line-powered, mobileAn 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 mains electricity (AC-powered) electromechanical injectors (e.g., syringe piston drivers, tubing roller pumps) capable of delivering media with the pressure, flow range, and volume required for CT studies, and is mobile (e.g., on a wheeled pedestal). The system may synchronize media delivery with the x-ray generator during CT scanning.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315494757
Device count
1
Combination product
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536085330neon3CS 3922-4102026-05-28
04052536085361neon3CS 3924-4102026-05-28
04052536085491neon3CS 39302026-05-28
04052536085507neon3CS 39312026-05-28
04052536085552neon3CS 39342026-05-28
04052536161836neon3CS 3926-032026-05-28
04052536161867neon3CS 3927-032026-05-28
04052536161959neon3CS 3936-012026-05-28
04052536161966neon3CS 3937-032026-05-28
04052536161973neon3CS 3937-042026-05-28
04052536161775neon3CS 3920-012026-05-26
04052536216710neon3CS 3921-012026-05-26
04052536085323N/ACS 3921-02CS 3921-022016-09-22
04052536085347N/ACS 3923-01CS 3923-012016-09-22
04052536085354N/ACS 3923-02CS 3923-022016-09-22
04052536085460N/ACS 3929-02CS 3929-022016-09-22
04052536085484N/ACS 3929-04CS 3929-042016-09-22
04052536085521N/ACS 3932-02CS 3932-022016-09-22
04052536085545N/ACS 3933CS 39332016-09-22
04052536161782neon³ CT spinal stabilizationCS 3925-01CS 3925-012016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09345390003523MEDRAD® Centargo Patient Line (350 cm)IMAXEON PTY LTDIZQ2026-05-06
09345390003530MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-12-10
00616258025186MEDRAD® Stellant CT Injection SystemBayer Medical Care Inc.IZQ2025-12-10
00616258027333MEDRAD® Stellant FLEX CT Injection System with Certegra® WorkstationBayer Medical Care Inc.IZQ2025-12-10
10841716103442CT Exprès Bottle Spike AACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
10841716103466CT Exprès Day Set III HPACIST MEDICAL SYSTEMS, INC.IZQ2025-12-09
10841716103480CT Exprès Patient SetACIST MEDICAL SYSTEMS, INC.IZQ2025-08-15
09345390002656MEDRAD® Centargo Patient LineIMAXEON PTY LTDIZQ2025-03-28
09345390002717MEDRAD® Centargo Replacement SpikeIMAXEON PTY LTDIZQ2025-03-28
09345390003097MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
49345390003095MEDRAD® Centargo Day Set IMAXEON PTY LTDIZQ2025-03-28
09345390003349MEDRAD® Centargo CT Injection SystemIMAXEON PTY LTDIZQ2025-03-28
17630039302051Remote ControlBracco Injeneering SAIZQ2024-05-29
04052536166459ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166473ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175130ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175222ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203642ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203673ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203703ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203833ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203857ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166466ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536166480ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175147ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536175239ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203659ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203697ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203710ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29
04052536203840ulrich medical disposablesUlrich GmbH & Co. KGIZQ2024-05-29