MOSAIC®

GUDID 00613994479020

VALVE 305C227 MOSAIC AOR CINCHII US

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00613994479020
• NIH Device Record Key: e3f1d1dc-61c5-4024-9e8e-69f3694123d3
• Commercial Distribution Discontinuation: 2016-08-29
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: MOSAIC®
• Version Model Number: 305C227
• Company DUNS: 006261481
• Company Name: MEDTRONIC, 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: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994479020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P990064

FDA Product Code

• LWR: heart-valve, non-allograft tissue

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2014-09-23

On-Brand Devices [MOSAIC®]

• 00613994760760: VALVE 305C219 MOSAIC AOR CINCHII US
• 00613994760746: VALVE 305C221 MOSAIC AOR CINCHII US
• 00613994760739: VALVE 305C223 MOS AOR CINCHII NNA US
• 00613994760722: VALVE 305C223 MOSAIC AOR CINCHII US
• 00613994760715: VALVE 305C225 MOS AOR CINCHII NNA US
• 00613994760708: VALVE 305C225 MOSAIC AOR CINCHII US
• 00613994760692: VALVE 305C227 MOSAIC AOR CINCHII US
• 00613994760685: VALVE 305C229 MOSAIC AOR CINCHII US
• 00613994689207: VALVE 310C27 MOSAIC MIT CINCH US
• 00613994689139: VALVE 310C25 MOSAIC MIT CINCH US
• 00613994689061: VALVE 310C33 MOSAIC MIT CINCH US
• 00613994688996: VALVE 310C31 MOSAIC MIT CINCH US
• 00613994688927: VALVE 310C29 MOSAIC MIT CINCH US
• 00613994479136: VALVE 305C219 MOSAIC AOR CINCHII US
• 00613994479129: VALVE 305C221 MOSAIC AOR CINCHII US
• 00613994479112: VALVE 305C223 MOSAIC AOR CINCHII US
• 00613994479105: VALVE 305C225 MOSAIC AOR CINCHII US
• 00613994479020: VALVE 305C227 MOSAIC AOR CINCHII US
• 00613994479013: VALVE 305C229 MOSAIC AOR CINCHII US
• 00643169001954: VLV 305C229 MOSAIC AOR CII US TEMP IND
• 00643169001794: VLV 305C219 MOSAIC AOR CII US TEMP IND
• 00643169001787: VLV 305C219 MOSAIC AOR CII NNA US TEMP I
• 00643169001763: VLV 305C221 MOSAIC AOR CII US TEMP IND
• 00643169001756: VLV 305C221 MOSAIC AOR CII NNA US TEMP I
• 00643169001732: VLV 305C223 MOSAIC AOR CII US TEMP IND
• 00643169001725: VLV 305C223 MOSAIC AOR CII NNA US TEMP I
• 00643169001701: VLV 305C225 MOSAIC AOR CII US TEMP IND
• 00643169001695: VLV 305C225 MOSAIC AOR CII NNA US TEMP I
• 00643169001671: VLV 305C227 MOSAIC AOR CII US TEMP IND
• 00643169001657: VLV 310C25 MOSAIC MIT CINCH US TEMP IND
• 00643169001633: VLV 310C27 MOSAIC MIT CINCH US TEMP IND
• 00643169001619: VLV 310C29 MOSAIC MIT CINCH US TEMP IND
• 00643169001596: VLV 310C31 MOSAIC MIT CINCH US TEMP IND
• 00643169001572: VLV 310C33 MOSAIC MIT CINCH US TEMP IND
• 00643169594876: VLV 310C33 MOSAIC MIT CINCH US PEEK
• 00643169594869: VLV 310C31 MOSAIC MIT CINCH US PEEK
• 00643169594852: VLV 310C29 MOSAIC MIT CINCH US PEEK
• 00643169594845: VLV 310C27 MOSAIC MIT CINCH US PEEK
• 00643169594838: VLV 310C25 MOSAIC MIT CINCH US PEEK
• 00643169594760: VLV 305C225 MOSAIC AOR CII NNA US PEEK
• 00643169594753: VLV 305C223 MOSAIC AOR CII NNA US PEEK
• 00643169594746: VLV 305C221 MOSAIC AOR CII NNA US PEEK
• 00643169594739: VLV 305C219 MOSAIC AOR CII NNA US PEEK
• 00643169594722: VLV 305C229 MOSAIC AOR CII US PEEK
• 00643169594715: VLV 305C227 MOSAIC AOR CII US PEEK
• 00643169594708: VLV 305C225 MOSAIC AOR CII US PEEK
• 00643169594692: VLV 305C223 MOSAIC AOR CII US PEEK
• 00643169594685: VLV 305C221 MOSAIC AOR CII US PEEK
• 00643169594678: VLV 305C219 MOSAIC AOR CII US PEEK
• 00721902694776: VALVE 305C29 MOSAIC AOR CINCH US NCE