MEDRAD® Mark 7 Arterion Handswitch 12’ Optional ART 700 HS12

GUDID 00616258027227

ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530)

Bayer Medical Care Inc.

Contrast medium injection system hand controller kit

• Primary Device ID: 00616258027227
• NIH Device Record Key: 34b03884-2a28-4ec9-9e8a-9ebdeb7c5664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark 7 Arterion Handswitch 12’ Optional
• Version Model Number: ART 700 HS12
• Catalog Number: ART 700 HS12
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• 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 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	00616258027227 [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 Handswitch 12’ Optional]

• 00616258025322: ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (87978478)
• 00616258027227: ASSY,CBL,HANDSWITCH,EXTENDED,LR,UDI (89234530)