MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) TAG C150 HPCT

GUDID 40616258010166

Twist & Go HPCT, CoEx, 60'' (SET,PKGD,TWIST-GO,CO-EX,60",UV,MC,JA2) (85239090)

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 40616258010166
• NIH Device Record Key: 05b38323-b694-4f18-8516-d5e11f69d27b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in)
• Version Model Number: TAG C150 HPCT
• Catalog Number: TAG C150 HPCT
• 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	00616258010168 [Primary]
GS1	40616258010166 [Package]; Contains: 00616258010168; 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: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 150cm (60in) ]

• 10616258007134: "Twist & Go, HPCT, CoEx, 60'' (SET,PACKAGED,TWIST-GO,CO-EX, 60"",UV,MC,J) (84196975)"
• 10616258006953: Twist & Go, HPCT, CoEx, 60'' (ANGIO - ART, HPCT, TWIST & GO, CO-EX, 60") (60766876)
• 40616258010166: Twist & Go HPCT, CoEx, 60'' (SET,PKGD,TWIST-GO,CO-EX,60",UV,MC,JA2) (85239090)
• 40616258021520: ASSY,TBG,TWIST-GO,60”,UV,MC,WLD (86566818)