MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in) TAG C50 HPCT

GUDID 10616258007103

"Twist & Go HPCT, CoEx, 20'' (SET,PACKAGED,TWIST-GO,CO-EX,20"",UV,MC,JA) (84196762)"

BAYER MEDICAL CARE INC.

Radiographic procedure tubing

• Primary Device ID: 10616258007103
• NIH Device Record Key: 34cbfe70-b02c-4016-8b72-6741de0211a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in)
• Version Model Number: TAG C50 HPCT
• Catalog Number: TAG C50 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258007106 [Primary]
GS1	10616258007103 [Package]; Contains: 00616258007106; 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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [MEDRAD® Twist & Go Sterile High Pressure Connector Tubing, 50cm (20in)]

• 10616258007103: "Twist & Go HPCT, CoEx, 20'' (SET,PACKAGED,TWIST-GO,CO-EX,20"",UV,MC,JA) (84196762)"
• 10616258006960: Twist & Go HPCT, CoEx, 20'' (ANGIO - ART, HPCT, TWIST & GO, CO-EX, 20") (60766825)
• 40616258010135: Twist & Go HPCT, CoEx, 20'' (SET,PKGD,TWIST-GO,CO-EX,20",UV,MC,JA2) (85244221)