3f®

GUDID 00613994961594

THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR

MEDTRONIC 3F THERAPEUTICS, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00613994961594
• NIH Device Record Key: d18d1c71-af4d-4714-b524-8bf1317bb45b
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3f®
• Version Model Number: 1000-27
• Company DUNS: 079527232
• Company Name: MEDTRONIC 3F THERAPEUTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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
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• 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
• 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	00613994961594 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060025

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 [3f®]

• 00613994868268: THV 1000-29 3F AORTIC BIO 29MM
• 00613994868251: THV 1000-27 3F AORTIC BIO 27MM
• 00613994868244: THV 1000-25 3F AORTIC BIO 25MM
• 00613994868237: THV 1000-23 3F AORTIC BIO 23MM
• 00613994868220: THV 1000-21 3F AORTIC BIO 21MM
• 00613994868213: THV 1000-29 3F AORTIC BIO 29MM 1 EA US
• 00643169072558: THV 1000-29 3F AORTIC BIO 29MM 1 EA US
• 00643169072541: THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR
• 00643169072534: THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR
• 00643169072527: THV 1000-25 3F AORTIC BIO 25MM 2PC HLDR
• 00643169072510: THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR
• 00643169072503: THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR
• 00613994961624: THV 1000-21 3F AORTIC BIO 21MM 2PC HLDR
• 00613994961617: THV 1000-23 3F AORTIC BIO 23MM 2PC HLDR
• 00613994961600: THV 1000-25 3F AORTIC BIO 25MM 2PC HLDR
• 00613994961594: THV 1000-27 3F AORTIC BIO 27MM 2PC HLDR
• 00613994961587: THV 1000-29 3F AORTIC BIO 29MM 2PC HLDR
• 00613994959720: THV 1000-29 3F AORTIC BIO 29MM 1 EA US