MEDRAD Imaging Bulk Package Transfer Spike GBP TS

GUDID 40616258022367

ASSY,IBP TRANSFER SPIKE,FINAL (86613735)

Bayer Medical Care Inc.

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• 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.

• 40616258022367 - MEDRAD Imaging Bulk Package Transfer Spike: 2024-04-23ASSY,IBP TRANSFER SPIKE,FINAL (86613735)
• 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)