MEDRAD Imaging Bulk Package Transfer Spike GBP TS

GUDID 40616258022367

ASSY,IBP TRANSFER SPIKE,FINAL (86613735)

Bayer Medical Care Inc.

Fluid transfer set, general-purpose

• Primary Device ID: 40616258022367
• NIH Device Record Key: 6bcba898-903d-4353-96e3-2922c8eea0e8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD Imaging Bulk Package Transfer Spike
• Version Model Number: GBP TS
• Catalog Number: GBP TS
• Company DUNS: 049673973
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616258022369 [Primary]
GS1	40616258022367 [Package]; Contains: 00616258022369; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200280

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: 2024-04-23
• Device Publish Date: 2024-04-15

Devices Manufactured by Bayer Medical Care Inc.

• 00616258025131 - MEDRAD® Stellant CT Injection System: 2024-11-11
• 00616258024042 - MEDRAD® Avanta Single Patient Disposable Set - Angio: 2024-07-16 ASSY,TBG,SNGL,ANGIO,65",MC,CORE (87629066)
• 40616258024002 - MEDRAD® Avanta Multi-Patient Disposable Set: 2024-07-12 ASSY,TBG,MULTI,ANGIO,MC,CORE (87629007)
• 40616258024088 - MEDRAD® Avanta Single Patient Disposable Set – Transducer Compatible: 2024-07-11 ASSY,TBG,SNGL,ANGIO,65",PIV,MC,CORE (87629104)
• 00616258027340 - Imaging System Interface - ISI2 Module: 2024-06-25 ASSY,MODULE,ISI2,CORE (89302900)
• 00616258022512 - Imaging System Interface - ISI2 Module: 2024-05-14 ASSY, Module, ISI2 (86882302)
• 00616258023793 - MEDRAD® Mark 7 Arterion Injection System: 2024-05-14 MARK 7 ARTERION,PKG,BASE SYSTEM,4TH,LR (87469921)
• 40616258024309 - Disposable MRI Kit with Check Valve: 2024-05-14 SPECTRIS,KIT,SYR,MRI,65ML,CHK,MC,CORE (87622444)