MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT 200-FT-Q

GUDID 40616258011002

200 ML FasTurn Syringe with Quick Fill Tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSEY,RU,MC) (85687263)

BAYER MEDICAL CARE INC.

Angiographic syringe Angiographic syringe

• Primary Device ID: 40616258011002
• NIH Device Record Key: 3e5f41c6-be49-4a1f-9192-75956fc073a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT
• Version Model Number: 200-FT-Q
• Catalog Number: 200-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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258011004 [Primary]
GS1	40616258011002 [Package]; Contains: 00616258011004; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K822536

FDA Product Code

• DXT: Injector And Syringe, Angiographic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-02

On-Brand Devices [MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe & QFT]

• 40616258011002: 200 ML FasTurn Syringe with Quick Fill Tube (ASSY,PKG,SYR,200ML W/QFT,ODYSSEY,RU,MC) (85687263)
• 10616258007912: "200 ML FasTurn Syringe with Quick Fill Tube (SET,PKG200ML FASTURN,W/QFT,RADSTAB,MC,CH) (8422009
• 10616258005628: 200 ML FasTurn Syringe with Quick Fill Tube (ANGIO-SET,PKG,200ML FASTURN SYR W/QFT,MC) (60729695
• 40616258021810: PROVIS,KIT,SYR,ANGIO,200ML,MC,WLD (86617560)