MEDRAD eCoil 3.0T Endo Interface Kit 8624855

GUDID 00616258021072

ASSY,PKG,KIT,SIEMENS,TIM,3T,ECOIL,ID,MC (84624527)

BAYER MEDICAL CARE INC.

MRI system coil, radio-frequency MRI system coil, radio-frequency

• Primary Device ID: 00616258021072
• NIH Device Record Key: 757180df-f111-4335-a1ab-4f22d7c8f27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD eCoil 3.0T Endo Interface Kit
• Version Model Number: 8624855
• Catalog Number: 8624855
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• 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	00616258021072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051349

FDA Product Code

• MOS: Coil, Magnetic Resonance, Specialty

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-03-05
• Device Publish Date: 2017-12-18

Devices Manufactured by BAYER MEDICAL CARE INC.

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• 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)