MEDRAD® Imaging Bulk Package Transfer Set IBP TS

GUDID 40616258008194

ASSEMBLY,FINAL,IBPTS, MC (CT - SWABBABLE VALVE TRANSFER SET, SVTS) (85199579)

BAYER MEDICAL CARE INC.

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• Primary Device ID: 40616258008194
• NIH Device Record Key: 3a477b79-9da6-4eee-b5b7-ecbd1d76f3bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® Imaging Bulk Package Transfer Set
• Version Model Number: IBP TS
• Catalog Number: IBP TS
• 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: false
• 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
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• Phone: +1(800)633-7231
• Email: ricustomercomplaints@bayer.com
• 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	00616258008196 [Primary]
GS1	40616258008194 [Package]; Contains: 00616258008196; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173913

FDA Product Code

• PQH: Iodinated Contrast Media Transfer Tubing Set

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: 2018-09-03
• Device Publish Date: 2018-08-03

Devices Manufactured by BAYER MEDICAL CARE INC.

• 40616258022367 - MEDRAD Imaging Bulk Package Transfer Spike: 2024-04-23 ASSY,IBP TRANSFER SPIKE,FINAL (86613735)
• 40616258027133 - Low Pressure Connector Tubing: 2024-04-22 ASSY,TUBE,SET,LPDCT 160,MICR,WLD,FINAL (890030204)
• 00616258021379 - MEDRAD® Intego PET Infusion System: 2023-05-11 SYSTEM,INTEGO,INT SYS 200,4ED,MC (86443090)
• 00616258025360 - MEDRAD® Intego PET Infusion System: 2023-05-11 SYSTEM,INTEGO,INT SYS 200,4ED,WS (87978443)
• 40616258026440 - Low Pressure Connector Tubing Integral “T” with Check Valve: 2022-10-24 ASSY,TBG,SNGL,LPCT,60",T-CONN,CV,MC,CORE (88454251)
• 00616258025377 - MEDRAD® Stellant Handswitch: 2022-05-02 ASSY,KIT,HAND SWITCH,LR, STELLANT (87980049)
• 00616258025384 - MEDRAD® Stellant Heat Maintainer: 2022-05-02 MAINTAIN,SYR HEAT,STELL,FLS2,LR (87980030)
• 00616258026206 - MEDRAD® MRXperion MR Injection System Handswitch: 2022-05-02 ASSY,KIT,HAND SWITCH,LR,MRXP (88311515)