HANCOCK®

GUDID 00681490908788

CONDUIT HC15018 HKI MO 10L

MEDTRONIC, INC.

Pulmonary heart valve bioprosthesis

• Primary Device ID: 00681490908788
• NIH Device Record Key: c8b49c70-19f0-4349-a726-a8be7d2e976c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HANCOCK®
• Version Model Number: HC15018
• 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	00681490908788 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P790007

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 [HANCOCK®]

• 00613994796042: CONDUIT H174A18 LV CONNECTOR 12L
• 00613994796035: CONDUIT H174A16 LV CONNECTOR 12L
• 00613994796028: CONDUIT H174A14 LV CONNECTOR 12L
• 00613994796011: CONDUIT H174A12 LV CONNECTOR 12L
• 00613994578686: CONDUIT 174A-20 LV CONNECTOR US
• 00613994578679: CONDUIT 174A-18 LV CONNECTOR US
• 00613994578662: CONDUIT 174A-16 LV CONNECTOR US
• 00681490908832: CONDUIT HC15025 HKI MO 10L
• 00681490908818: CONDUIT HC15022 HKI MO 10L
• 00681490908795: CONDUIT HC15020 HKI MO 10L
• 00681490908788: CONDUIT HC15018 HKI MO 10L
• 00681490908764: CONDUIT HC15016 HKI MO 10L
• 00681490908740: CONDUIT HC150-14 HKI MO 10L
• 00681490908726: CONDUIT HC150-12 HKI MO 10L
• 00681490908696: CONDUIT HC105-26 HKI LOW POROSITY 10L
• 00681490908641: CONDUIT HC105-22 HKI LOW POROSITY 10L
• 00681490908597: CONDUIT HC105-20 HKI LOW POROSITY 10L
• 00681490908559: CONDUIT HC105-18 HKI LOW POROSITY 10L
• 00681490908528: CONDUIT HC105-16 HKI LOW POROSITY 10L
• 00681490908504: CONDUIT HC105-14 HKI LOW POROSITY 10L
• 00681490908474: CONDUIT HC105-12 HKI LOW POROSITY 10L