Avalus Ultra™

GUDID 00763000647049

AVALUSTM ULTRA 400U23 23MM VALVE SIZE

MEDTRONIC, INC.

Aortic heart valve bioprosthesis

• Primary Device ID: 00763000647049
• NIH Device Record Key: b6272a4e-64e1-4cc1-9e46-9c89a493c7ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalus Ultra™
• Version Model Number: 400U23
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: true
• 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
• 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
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not expose the valve to sunlight or other ultraviolet light sources, or placed where significant temperature fluctuations could occur.
• Storage Environment Temperature: Between 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000647049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P170006

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-13
• Device Publish Date: 2024-05-04

On-Brand Devices [Avalus Ultra™]

• 00763000647094: AVALUSTM ULTRA 7400SU SIZERS
• 00763000647070: AVALUSTM ULTRA 400U29 29MM VALVE SIZE
• 00763000647063: AVALUSTM ULTRA 400U27 27MM VALVE SIZE
• 00763000647056: AVALUSTM ULTRA 400U25 25MM VALVE SIZE
• 00763000647049: AVALUSTM ULTRA 400U23 23MM VALVE SIZE
• 00763000647032: AVALUSTM ULTRA 400U21 21MM VALVE SIZE
• 00763000647025: AVALUSTM ULTRA 400U19 19MM VALVE SIZE