HANCOCK II ULTRA®

GUDID 00643169594524

VLV T505U221 HKII AORULT CII US PEEK

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00643169594524
• NIH Device Record Key: 259285e5-f5a2-47b6-8e79-b2cdf12b3378
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANCOCK II ULTRA®
• Version Model Number: T505U221
• 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	00643169594524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P980043

FDA Product Code

• DYE: replacement Heart-valve

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: 2015-10-07

On-Brand Devices [HANCOCK II ULTRA®]

• 00613994772756: VALVE T505U229 HKII AOR ULT CINCHII US
• 00613994772749: VALVE T505U227 HKII AOR ULT CINCHII US
• 00613994772732: VALVE T505U225 HKII AOR ULT CINCHII US
• 00613994772725: VALVE T505U223 HKII AOR ULT CINCHII US
• 00613994772718: VALVE T505U221 HKII AOR ULT CINCHII US
• 00643169000292: VLV T505U229 HKII AOR ULT CII US TEMP IN
• 00643169000278: VLV T505U227 HKII AOR ULT CII US TEMP IN
• 00643169000254: VLV T505U225 HKII AOR ULT CII US TEMP IN
• 00643169594616: VLV T505U229 HKII AORULT CII NNA US PEEK
• 00643169594609: VLV T505U227 HKII AORULT CII NNA US PEEK
• 00643169594593: VLV T505U225 HKII AORULT CII NNA US PEEK
• 00643169594586: VLV T505U223 HKII AORULT CII NNA US PEEK
• 00643169594579: VLV T505U221 HKII AORULT CII NNA US PEEK
• 00643169594562: VLV T505U229 HKII AORULT CII US PEEK
• 00643169594555: VLV T505U227 HKII AORULT CII US PEEK
• 00643169594548: VLV T505U225 HKII AORULT CII US PEEK
• 00643169594531: VLV T505U223 HKII AORULT CII US PEEK
• 00643169594524: VLV T505U221 HKII AORULT CII US PEEK
• 00643169534124: VLV T505U229 HKII AORULT CII NNA US TEMP
• 00643169534117: VLV T505U227 HKII AORULT CII NNA US TEMP
• 00643169534100: VLV T505U225 HKII AORULT CII NNA US TEMP
• 00643169534094: VLV T505U223 HKII AORULT CII NNA US TEMP
• 00643169534087: VLV T505U221 HKII AORULT CII NNA US TEMP