FDA.reportPublic FDA data

ulrich medical disposables

Primary DI
04052536175130
Brand
ulrich medical disposables
Company
Ulrich GmbH & Co. KG
Model
XD 10716
Device description
Easy-Click-Cassette 3 - flex for ulricheasyINJECT CT/MRI injectors
Published
2024-05-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K233737000
K241850000
K252281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233737000ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG2024-04-19IZQ
K241850000ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG2024-08-26IZQ
K252281000ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)Ulrich GmbH & Co. KG2025-11-18IZQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04052536175147PackageGS110In Commercial Distribution
04052536175154PackageGS14In Commercial Distribution
04052536175130PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04052536175147040525361751474052536175147
04052536175154040525361751544052536175154
04052536175130040525361751304052536175130

GMDN Terms#

Term, Definition table
TermDefinition
Contrast medium injection system administration setA 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 tubing with switches/valves and connectors to syringes/fluid/contrast medium injection system, and possibly a pressure transducer; it is typically made of plastic materials. This is a disposable device which may serve multiple patients before being discarded.

Regulatory Flags#

DUNS number
315494757
Device count
1
DM exempt
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04052536052912uCentumUL 8525-232025-08-04
04052536078264uCentumCS 71382025-08-01
04052536078271uCentumCS 71402025-08-01
04052536078295uCentumCS 71442025-08-01
04052536176823N/ACS 3993-900CS 3993-9002019-05-21
04052536164417N/ACS 3995-003-000CS 3995-003-0002018-02-14
04052536164530N/ACS 3995-002-000CS 3995-002-0002018-02-14
04052536164547N/ACS 3995-001-000CS 3995-001-0002018-02-14
04052536164554N/ACS 3995-001-001CS 3995-001-0012018-02-14
04052536164615N/ACS 3994-001-004CS 3994-001-0042018-02-14
04052536164622N/ACS 3995-001-002CS 3995-001-0022018-02-14
04052536085620N/ACS 3938-03CS 3938-032016-09-22
04052536085705N/ACS 3944-02CS 3944-022016-09-22
04052536085781N/ACS 3952-01CS 3952-012018-02-14
04052536085798N/ACS 3952-02CS 3952-022018-02-14
04052536085811N/ACS 3954-01CS 3954-012018-02-14
04052536085866N/ACS 3961CS 39612016-09-22
04052536161980N/ACS 3939-01CS 3939-012016-09-22
04052536162024N/ACS 3944-03CS 3944-032016-09-22
04052536162031N/ACS 3945-01CS 3945-012016-09-22

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
04052536230495ulrichINJECT CT motionUlrich GmbH & Co. KGIZQ2025-12-02
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
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