MEDRAD® Mark 7 Arterion Injection System ART 700

GUDID 00616258023793

MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921)

Bayer Medical Care Inc.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258023793
• NIH Device Record Key: e71d6337-f4df-4626-a4ba-86699b6f6f39
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark 7 Arterion Injection System
• Version Model Number: ART 700
• Catalog Number: ART 700
• Company DUNS: 049673973
• 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
• 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
• 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
• 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
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258023793 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113133

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: 2024-05-14
• Device Publish Date: 2024-05-06

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

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• 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)
• 00616258026329: MARK 7 ARTERION,PKG,BASE SYSTEM,LATAM,LR (88353781)
• 00616258026312: MARK 7 ARTERION,PKG,BASE SYSTEM,RU,LR (88351614)
• 00616258026305: MARK 7 ARTERION,PKG,BASE SYSTEM,JA,LR (88351606)
• 00616258026299: MARK 7 ARTERION,PKG,BASE SYSTEM,CHINA,LR (88351630)
• 00616258023793: MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921)