Avalus™

GUDID 00643169976399

SIZERS 7400S AVALUS CEM GLOBAL

MEDTRONIC, INC.

Heart valve sizer, reusable Heart valve sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable Heart valve annulus sizer, reusable

• Primary Device ID: 00643169976399
• NIH Device Record Key: 67b3aa11-de69-4410-b463-4d57b25b9615
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Avalus™
• Version Model Number: 7400S
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169976399 [Primary]

FDA Product Code

• DTI: SIZER, HEART-VALVE, PROSTHESIS

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

[00643169976399]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-10-14

On-Brand Devices [Avalus™]

• 00643169983212: VALVE 40027 AVALUS AOR MMX U30 US
• 00643169983205: VALVE 40025 AVALUS AOR MMX U30 US
• 00643169983199: VALVE 40023 AVALUS AOR MMX U30 US
• 00643169983182: VALVE 40021 AVALUS AOR MMX U30 US
• 00643169983175: VALVE 40019 AVALUS AOR MMX U30 US
• 00643169976405: HANDLE 7420 VLV HNDLE 234MM CEM GLOBAL
• 00643169976399: SIZERS 7400S AVALUS CEM GLOBAL
• 00643169983229: VALVE 40029 AVALUS AOR MMX U30 US