MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube TAG 150 SYR

GUDID 40616258021728

TAG,KIT,SYR,ANGIO,150ML,MC,WLD2 (86595680)

BAYER MEDICAL CARE INC.

Angiographic syringe

• Primary Device ID: 40616258021728
• NIH Device Record Key: 2241c1f7-3d55-45e1-bbf4-9529fffd1950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube
• Version Model Number: TAG 150 SYR
• Catalog Number: TAG 150 SYR
• 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	00616258021720 [Primary]
GS1	40616258021728 [Package]; Contains: 00616258021720; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131517

FDA Product Code

• FPK: Tubing, Fluid Delivery

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: 2019-11-04
• Device Publish Date: 2019-10-25

On-Brand Devices [MEDRAD® Twist & Go Disposable Syringe 150 mL with Quick Fill Tube]

• 40616258010074: Twist & Go Syringe Kit, 150 ML (SYRINGE KIT,PKG,MEDRAD,150QFT,TAG,MC,JA2) (85232894)
• 10616258007097: "Twist & Go Syringe Kit, 150 ML (SYRINGE KIT,PKG,MEDRAD,150QFT,TAG,MC,JA) (84196754)"
• 10616258006984: Twist & Go Syringe Kit, 150 ML (ANGIO - ARTERION, TWIST & GO150ML SYR w/QFT, MC) (60766817)
• 40616258021728: TAG,KIT,SYR,ANGIO,150ML,MC,WLD2 (86595680)
• 40616258021711: TAG,KIT,SYR,ANGIO,150ML,MC,WLD (86617463)