Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye SQK 65S

GUDID 10616258005512

MRI Integral ”T” with Check Valve for MEDRAD® Spectris MR Injector (Contents: 1 - 96" Low Pressure Connector Tube with T-Connector and Check Valve) (MR - SPECTRIS SYRINGE KIT, 2-65ML) (60728516)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 10616258005512
• NIH Device Record Key: 788bd0c1-47cd-4683-bc81-7024cb02735b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable MRI Kit A Disposable Kit for use with the 65/65 MR Injector from Baye
• Version Model Number: SQK 65S
• Catalog Number: SQK 65S
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258005515 [Primary]
GS1	10616258005512 [Package]; Contains: 00616258005515; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980417

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by BAYER MEDICAL CARE INC.

• 00616258024042 - MEDRAD® Avanta Single Patient Disposable Set - Angio: 2024-07-16 ASSY,TBG,SNGL,ANGIO,65",MC,CORE (87629066)
• 40616258024002 - MEDRAD® Avanta Multi-Patient Disposable Set: 2024-07-12 ASSY,TBG,MULTI,ANGIO,MC,CORE (87629007)
• 40616258024088 - MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible: 2024-07-11 ASSY,TBG,SNGL,ANGIO,65",PIV,MC,CORE (87629104)
• 00616258027340 - Imaging System Interface - ISI2 Module: 2024-06-25 ASSY,MODULE,ISI2,CORE (89302900)
• 00616258022512 - Imaging System Interface - ISI2 Module: 2024-05-14 ASSY, Module, ISI2 (86882302)
• 00616258023793 - MEDRAD® Mark 7 Arterion Injection System: 2024-05-14 MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921)
• 40616258024309 - Disposable MRI Kit with Check Valve: 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)
• 40616258024316 - Disposable MRI Kit for 65/115 MR Injector System: 2024-05-14 SOLARIS,KIT,SYR,MRI,65/115ML,MC,CORE (87622460)