Female - Female Adapter FFA 50

GUDID 40616258010111

MR Female to Female Adapter (KIT,ADAPTR,FEMALE-FEMALE LUER,MRI,MC,JA2) (85231502)

BAYER MEDICAL CARE INC.

Fluid transfer set, general-purpose

• Primary Device ID: 40616258010111
• NIH Device Record Key: af423ad3-d188-42b1-9a39-f2686a1a3f13
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Female - Female Adapter
• Version Model Number: FFA 50
• Catalog Number: FFA 50
• 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: true
• 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	00616258010113 [Primary]
GS1	40616258010111 [Package]; Contains: 00616258010113; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K980417

FDA Product Code

• LNH: System, Nuclear Magnetic Resonance Imaging

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: 2019-05-28
• Device Publish Date: 2019-05-20

On-Brand Devices [Female - Female Adapter ]

• 10616258007271: "MR Female to Female Adapter (KIT,ADAPTER,FEMALE-FEMALE LUER,MRI,MC,JA) (84194921)"
• 10616258005673: MR Female to Female Adapter (MR - FEMALE-FEMALE LUER ADAPTER) (60729229)
• 40616258010111: MR Female to Female Adapter (KIT,ADAPTR,FEMALE-FEMALE LUER,MRI,MC,JA2) (85231502)
• 40616258021667: ASSY,FEMALE-FEMALE LUER,MRI, MC,WLD (86574470)