3f®

GUDID 00613994868268

THV 1000-29 3F AORTIC BIO 29MM

MEDTRONIC 3F THERAPEUTICS, INC.

Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis Aortic heart valve bioprosthesis

• Primary Device ID: 00613994868268
• NIH Device Record Key: 72b4239b-f650-4ae6-9ab0-961f1ac10259
• Commercial Distribution Discontinuation: 2017-11-30
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: 3f®
• Version Model Number: 1000-29
• 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

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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	00613994868268 [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: 4
• 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