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Bayer Medical Care Inc.

United States·US-MF-000007050

Last updated September 17, 2026

Information

Country: United States
Address: 1, Bayer Drive, Indianola, United States
Website: bayer.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Joseph Kridgen
EUDAMED SRN: US-MF-000007050
FDA FEI Number: 2520313
DUNS Number: —

Catalogue (463)

Page 1 of 10

Device	Model / Reference	Registries	Class	Status
MEDRAD® Vflow Disposable Hand Controller	VF HC	EUDAMED	Class IIb	Active
MEDRAD® MRXperion 250cm Single Patient Disposable	XP SP2	EUDAMED	Class IIa	Active
MEDRAD® Veris™ 8600 Vital Signs Monitor	3010515	FDA UDI	Class II	Active
MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 75cm (30in)	TAG C75 HPCT	FDA UDI	Class II	Active
MEDRAD® Mark 7 Arterion Handswitch 12’ Optional	ART 700 HS12	FDA UDI	Class II	Active
MEDRAD® Stellant CT Injection System	Stellant D-CE	FDA UDI	Class II	Active
Display Control Unit Sheath	AVA 500 DCOV	FDA UDI	Class II	Active
Hand Controller Sheath	AVA 500 HCS	FDA UDI	Class II	Active
Low Pressure Connector Tubing Integral “T” with Check Valve	LP-60-T-CV	FDA UDI	Class II	Active
MEDRAD® Avanta Fluid Management Injection System	AVA 500 PEDL	FDA UDI	Class II	Active
Low Pressure Connector Tubing	LPDCT 160	FDA UDI	Class II	Active
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector	SIT 96V	FDA UDI	Class II	Active
Disposable MRI Kit with Check Valve	SQK 65VA	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-SPK	FDA UDI	Class II	Active
MEDRAD® Spectris Solaris EP MR Injection System	Spectris Solaris EP	FDA UDI	Class II	Active
CT TRI-PAK Sterile Disposable Syringe	CTP-200-FLS	FDA UDI	Class II	Active
Disposable MRI Kit for 65/115 MR Injector System	SSQK 65/115VS	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-QFT	FDA UDI	Class II	Active
Low Pressure Connector Tubing	LPDCT 160	FDA UDI	Class II	Active
MEDRAD® Veris™ 8600 Vital Signs Monitor	3011544	FDA UDI	Class II	Active
MEDRAD® Intego PET Infusion System	Intego	FDA UDI	Class II	Active
MEDRAD® Stellant CT Injection System	Stellant D	FDA UDI	Class II	Active
MEDRAD® Intego Patient Administration Set	INT CPS	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX Syringe Kit	FLEXD-150-SCS	FDA UDI	Class II	Active
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube	SSS-LP-60-T	FDA UDI	Class II	Active
MEDRAD® Stellant CT Injection System	SSH 100F	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation	Stellant FLEX	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-SPK	FDA UDI	Class II	Active
MEDRAD® Stellant Imaging System Interface 900	ISI 900S	FDA UDI	Class II	Active
CT TRI-PAK Sterile Disposable Syringe	CTP-200-FLS	FDA UDI	Class II	Active
MEDRAD® Spectris Solaris MRI Integral "T" with Check Valve	SSIT 96VLD	FDA UDI	Class II	Active
MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe	200-FT	FDA UDI	Class II	Active
10” (25 cm) High Pressure Connector Tube	DCT 100	FDA UDI	Class II	Active
MEDRAD® Stellant Low Pressure Connector Tubing with Prime Tube	SSS-LP-60-T	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX CT Injection System with Certegra® Workstation (Upgrade)	Stellant FLEX	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-SPK	FDA UDI	Class II	Active
Disposable MRI Kit for 65/115 MR Injector System	SSQK 65/115VS	FDA UDI	Class II	Active
MEDRAD eCoil 3.0T Endo Interface Kit	8624855	FDA UDI	Class II	Active
MEDRAD® Stellant Sterile Disposable Syringe	SDS-CTP-SCS	FDA UDI	Class II	Active
MEDRAD® Stellant FLEX Syringe Kit	FLEXD-200-SPK	FDA UDI	Class II	Active
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector	SIT 96V	FDA UDI	Class II	Active
MRI Integral "T" with Check Valve for MEDRAD® Spectris MR Injector	SIT 96V	FDA UDI	Class II	Active
Medrad® Pres	PRES50	FDA UDI	Class I	Active
MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT	200-FT-Q	FDA UDI	Class II	Active
MEDRAD® Avanta Single Patient Disposable Set - Transducer Compatable	AVA 500 SPAT L	FDA UDI	Class II	Active
Saline Syringe & Tubing for MR Injector System	SSQK 115	FDA UDI	Class II	Active
MEDRAD® Mark 7 Arterion Injection System	ART 700	FDA UDI	Class II	Active
MEDRAD® Intego PET Infusion System	INT VS BLK	FDA UDI	Class II	Active
MEDRAD® Veris™ 8600 Vital Signs Monitor	3011507	FDA UDI	Class II	Active
MEDRAD® Stellant CT Injection System	Stellant Sx	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

Bayer Medical Care B.V. NL

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Notified Bodies

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Authorities

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FDA Recalls (9)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Apr 24, 2026	Z-2296-2026	—	open, classified	Supplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer reports indicate that the stopcock cannot be reliably engaged with the CFCV snap interface. In instances where engagement is achieved through applied force, the connection is unstable, and the stopcock may disengage before or during contrast injection, leading to procedure interruption.
Nov 30, 2022	Z-0910-2023	—	open, classified	Black specks may be present on the packaged needles
Sep 14, 2021	Z-0199-2022	—	terminated	Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist & Go Syringes (TAG 150 SYR)
Oct 5, 2020	Z-0483-2021	—	terminated	Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have the potential to allow fluid to leak out of the syringe.
Dec 14, 2018	Z-0745-2019	—	terminated	If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.
Sep 7, 2018	Z-0097-2019	—	terminated	Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer conducted further testing confirming the dust cap may generate particulate which may potentially enter the fluid path.
Jun 28, 2018	Z-2960-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Jun 28, 2018	Z-2961-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.
Jun 28, 2018	Z-2962-2018	—	terminated	The torque wrench used on the ceiling column assembly during a recent service visit was outside of the torque specification, potentially overtightening the bolts. The overtightening of bolts may compromise the structural integrity of the system which could lead to the OCS disengaging from the ceiling mount and this may cause injury to the patient or the operator.