MOSAIC ULTRA®

GUDID 00643169001831

VLV 305U221 MOSAIC AOR ULT CII NNA US TE

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00643169001831
• NIH Device Record Key: b9cf7ef1-e091-465f-b80b-ef3eebda7fd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MOSAIC ULTRA®
• Version Model Number: 305U221
• 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	00643169001831 [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 ULTRA®]

• 00613994760661: VALVE 305U219 MOS AOR ULT CINCHII US
• 00613994760647: VALVE 305U221 MOS AOR ULT CINCHII US
• 00613994760630: VALVE 305U223 MOS AOR ULT CNCHII NNA US
• 00613994760623: VALVE 305U223 MOS AOR ULT CINCHII US
• 00613994760616: VALVE 305U225 MOS AOR ULT CNCHII NNA US
• 00613994760609: VALVE 305U225 MOS AOR ULT CINCHII US
• 00613994760593: VALVE 305U227 MOS AOR ULT CINCHII US
• 00613994760586: VALVE 305U229 MOS AOR ULT CINCHII US
• 00613994479365: VALVE 305U219 MOS AOR ULT CINCHII US
• 00613994479259: VALVE 305U221 MOS AOR ULT CINCHII US
• 00613994479242: VALVE 305U223 MOS AOR ULT CINCHII US
• 00613994479235: VALVE 305U225 MOS AOR ULT CINCHII US
• 00613994479228: VALVE 305U227 MOS AOR ULT CINCHII US
• 00613994479211: VALVE 305U229 MOS AOR ULT CINCHII US
• 00643169001879: VLV 305U219 MOSAIC AOR ULT CII US TEMP I
• 00643169001862: VLV 305U219 MOSAIC AOR ULT CII NNA US TE
• 00643169001848: VLV 305U221 MOSAIC AOR ULT CII US TEMP I
• 00643169001831: VLV 305U221 MOSAIC AOR ULT CII NNA US TE
• 00643169001664: VLV 305U223 MOSAIC AOR ULT CII US TEMP I
• 00643169001558: VLV 305U223 MOSAIC AOR ULT CII NNA US TE
• 00643169001534: VLV 305U225 MOSAIC AOR ULT CII US TEMP I
• 00643169001527: VLV 305U225 MOSAIC AOR ULT CII NNA US TE
• 00643169001503: VLV 305U227 MOSAIC AOR ULT CII US TEMP I
• 00643169001480: VLV 305U229 MOSAIC AOR ULT CII US TEMP I
• 00643169595026: VLV 305U225 MOSAIC AORULT CII NNAUS PEEK
• 00643169595019: VLV 305U223 MOSAIC AORULT CII NNAUS PEEK
• 00643169595002: VLV 305U221 MOSAIC AORULT CII NNAUS PEEK
• 00643169594999: VLV 305U219 MOSAIC AORULT CII NNAUS PEEK
• 00643169594982: VLV 305U229 MOSAIC AORULT CII US PEEK
• 00643169594975: VLV 305U227 MOSAIC AORULT CII US PEEK
• 00643169594968: VLV 305U225 MOSAIC AORULT CII US PEEK
• 00643169594951: VLV 305U223 MOSAIC AORULT CII US PEEK
• 00643169594944: VLV 305U221 MOSAIC AORULT CII US PEEK
• 00643169594937: VLV 305U219 MOSAIC AORULT CII US PEEK
• 00885074253305: VALVE 305U23 MOSAIC AOR ULTRA US
• 00885074253275: VALVE 305U29 MOSAIC AOR ULTRA US
• 00885074253268: VALVE 305U27 MOSAIC AOR ULTRA US
• 00885074253251: VALVE 305U25 MOSAIC AOR ULTRA US
• 00885074253244: VALVE 305U23 MOSAIC AOR ULTRA US
• 00885074253220: VALVE 305U21 MOSAIC AOR ULTRA US
• 00885074253213: VALVE 305U19 MOSAIC AOR ULTRA US