MEDRAD® Mark 7 Arterion Heat Maintainer, Syringe ART 700 HM

GUDID 00616258025339

ASSY,HEAT MAINTAINER,SYR,ARTER,LR,UDI (87978451)

BAYER MEDICAL CARE INC.

Angiography contrast medium injection system, line-powered, mobile

• Primary Device ID: 00616258025339
• NIH Device Record Key: 4eef8dac-8dc2-438e-932e-bebede321014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark 7 Arterion Heat Maintainer, Syringe
• Version Model Number: ART 700 HM
• Catalog Number: ART 700 HM
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: true
• 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 5 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258025339 [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: 2022-04-25
• Device Publish Date: 2022-04-15

On-Brand Devices [MEDRAD® Mark 7 Arterion Heat Maintainer, Syringe]

• 00616258025339: ASSY,HEAT MAINTAINER,SYR,ARTER,LR,UDI (87978451)
• 00616258027173: ASSY,HEAT MAINTAINER,SYRINGE,ARTERION,LR (89234549)