MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT 150-FT-Q

GUDID 40616258009924

150 ML FasTurn Syringe with Quick Fill Tube (ANGIO-SET,PKG,150ML FASTURN SYR W/QFT,MC,JA2) (85231464)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258009924
• NIH Device Record Key: 63651864-6f75-417f-a652-41546d028103
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark V ProVis Sterile Disposable Syringe 150mL & QFT
• Version Model Number: 150-FT-Q
• Catalog Number: 150-FT-Q
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258009926 [Primary]
GS1	40616258009924 [Package]; Contains: 00616258009926; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K903390

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® Mark V ProVis Sterile Disposable Syringe 150mL & QFT]

• 10616258007875: 150 ML FasTurn Syringe with Quick Fill Tube (SET,PKG,150ML FASTURN,W/QFT,RAD,MC,CH) (60729660)
• 10616258007431: 150 ML FasTurn Syringe with Quick Fill Tube (SET,PKG,150ML FASTURN,W/QFT,RAD,MC,LA) (60729644)
• 10616258005604: 150 ML FasTurn Syringe with Quick Fill Tube (ANGIO-SET,PKG,150ML FASTURN SYR W/QFT,MC) (60729636
• 10616258005536: 150 ML FasTurn Syringe with Quick Fill Tube (SET,PKG,150ML FT,W/QFT,RAD,JAPAN,MC) (60729679)
• 40616258009924: 150 ML FasTurn Syringe with Quick Fill Tube (ANGIO-SET,PKG,150ML FASTURN SYR W/QFT,MC,JA2) (8523
• 40616258021803: PROVIS,KIT,SYR,ANGIO,150ML,MC,WLD2 (86617528)
• 40616258021797: PROVIS,KIT,SYR,ANGIO,150ML,MC,WLD (86617552)