MEDRAD® Mark V ProVis 150mL FasTurn Sterile Disposable Syringe 150-FT

GUDID 40616258009931

SET,PKG,150ML FASTURN,RAD,JAPAN,MC,JA2 (85232878)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258009931
• NIH Device Record Key: 78c0521a-62a2-42bf-9b4b-5f8c08509969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Mark V ProVis 150mL FasTurn Sterile Disposable Syringe
• Version Model Number: 150-FT
• Catalog Number: 150-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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258009933 [Primary]
GS1	40616258009931 [Package]; Contains: 00616258009933; 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 150mL FasTurn Sterile Disposable Syringe ]

• 40616258009931: SET,PKG,150ML FASTURN,RAD,JAPAN,MC,JA2 (85232878)
• 10616258005598: 150 ML FasTurn Syringe (SET,PKG,150ML FASTURN,RAD,JAPAN,MC) (60729628)
• 10616258005581: 150 ML FasTurn Syringe (ANGIO - SET, PKG, 150ML FASTURN SYR, MC) (60729601)