Saline Syringe & Tubing for MR Injector System SSQK 115

GUDID 40616258010029

Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA2) (85233084)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe Angiographic syringe Angiographic syringe

• Primary Device ID: 40616258010029
• NIH Device Record Key: 7045aa15-e3a5-4f99-86ae-4a83d1fdf019
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Saline Syringe & Tubing for MR Injector System
• Version Model Number: SSQK 115
• Catalog Number: SSQK 115
• 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
• 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	00616258010021 [Primary]
GS1	40616258010029 [Package]; Contains: 00616258010021; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042784

FDA Product Code

• DXT: Injector And Syringe, Angiographic

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: 2018-02-02

On-Brand Devices [Saline Syringe & Tubing for MR Injector System]

• 40616258010029: Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA2) (852
• 00616258007021: Saline Syringe and Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC,JA) (8419
• 00616258005461: Saline Syringe & Tubing for MR Injector System (KIT,115ML 96" CT/INT T/CV,MRI, MR,MC) (60728605)
• 40616258021872: MR,KIT,SYR,MRI,115ML,96”,MC,WLD (86645556)
• 40616258024521: MR,KIT,SYR,MRI,115ML,96",MC,CORE (87622568)