MEDRAD® Mark 7 Arterion Injection System ART 700 PEDL, ART 700 TABL, ART 700 OCS, ART 700 B

GUDID 00616258020495

MARK 7 ARTERION,PKGD,BASE SYSTEM,JA,MC (85862219)

BAYER MEDICAL CARE INC.

Angiography contrast medium injection system, line-powered, mobile Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258020495
• NIH Device Record Key: 95e92de9-b80b-4b53-bd6b-a43d7ab59bcf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark 7 Arterion Injection System
• Version Model Number: Arterion
• Catalog Number: ART 700 PEDL, ART 700 TABL, ART 700 OCS, ART 700 B
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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	00616258020495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112086

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-14
• Device Publish Date: 2018-12-14

On-Brand Devices [MEDRAD® Mark 7 Arterion Injection System ]

• 00616258021362: MARK 7 ARTERION,PKGD,BASE SYSTEM,4th MC (86410095)
• 00616258020495: MARK 7 ARTERION,PKGD,BASE SYSTEM,JA,MC (85862219)
• 00616258009384: "ASSY, CA, HANDSWITCH, EXTENDED (85276549)"
• 00616258009377: "ASSY, CA, HAND SWITCH (85276522)"
• 00616258009360: "MARK 7 ARTERION, PACKAGED, BASE SYSTEM (60726793)"
• 00616258009353: "ANGIO - ARTERION, HEAT MAINTAINER (85276743)"
• 00616258009346: ASSY, FOOTSWITCH (85276506)
• 00616258022406: ARTERION,SYS,INJ,BASE,PKG,CHINA,4ED (86644355)