MEDRAD® eCoil Imaging System (for Philips Ingenia) 9896 030 19031

GUDID 00616258009179

"Assy, System, eCoil Interface Device, Philips Ingenia 3.0T (60727420)"

BAYER MEDICAL CARE INC.

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

• Primary Device ID: 00616258009179
• NIH Device Record Key: c5edf1ea-fe72-428a-9de2-7a65b30eb5f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MEDRAD® eCoil Imaging System (for Philips Ingenia)
• Version Model Number: 9896 030 19031
• Catalog Number: 9896 030 19031
• Company DUNS: 058716649
• Company Name: BAYER MEDICAL CARE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00616258009179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063342

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: 2016-09-24

On-Brand Devices [MEDRAD® eCoil Imaging System (for Philips Ingenia)]

• 10616258009268: "3.0T eCOIL (60727358)"
• 00616258009179: "Assy, System, eCoil Interface Device, Philips Ingenia 3.0T (60727420)"
• 00616258009162: "ASSY,FRU,ID,PHILIPS,INGENIA,3T,MC (60727412)"
• 00616258009148: "Assy.System,eCoil Interface Device, Philips Ingenia 1.5T (60727439)"
• 00616258009131: "ASSY,FRU,ID,PHILIPS,INGENIA,1.5T,MC (60727404)"