MEDRAD® Vflow Disposable Hand Controller VF HC

GUDID 40616258020165

Twist & Go Hand Controller Single ASSY,FINISHED,HC,VFLOW,MC,JA2 (85870084)

BAYER MEDICAL CARE INC.

Contrast medium injection system hand controller kit

• Primary Device ID: 40616258020165
• NIH Device Record Key: 8f8f434c-2c47-44ec-8e78-11e865cdfc5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Vflow Disposable Hand Controller
• Version Model Number: VF HC
• Catalog Number: VF HC
• 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: 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258020167 [Primary]
GS1	40616258020165 [Package]; Contains: 00616258020167; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132928

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [MEDRAD® Vflow Disposable Hand Controller ]

• 10616258006991: "Twist & Go Hand Controller Single (ANGIO - ART, VFLOW HAND CONTROLLER, MC) (84217107)"
• 40616258020165: Twist & Go Hand Controller Single ASSY,FINISHED,HC,VFLOW,MC,JA2 (85870084)
• 40616258021643: ASSY,HAND CONTROLLER,V-FLOW,MC,WLD (86574829)