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

GUDID 40616258010043

200 ML FasTurn Syringe (SET,PKG,200ML FSTRN,RAD STBLE SYR,MC,JA2) (85232983)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258010043
• NIH Device Record Key: b0472bc9-1eb9-4551-89b9-1849c7751073
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark V ProVis 200mL FasTurn Sterile Disposable Syringe
• Version Model Number: 200-FT
• Catalog Number: 200-FT
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258010045 [Primary]
GS1	40616258010043 [Package]; Contains: 00616258010045; 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 200mL FasTurn Sterile Disposable Syringe ]

• 10616258007066: "200 ML FasTurn Syringe (SET,PKG,200ML FASTURN,RAD STABLE SYRI,MC) (84196967)"
• 10616258005611: 200 ML FasTurn Syringe (ANGIO - SET, PKG, 200ML FASTURN SYR, MC) (60729687)
• 40616258010043: 200 ML FasTurn Syringe (SET,PKG,200ML FSTRN,RAD STBLE SYR,MC,JA2) (85232983)