EnVeo™ R

GUDID 00643169934115

LOADING SYSTEM LS-MDT2-23-US

MEDTRONIC COREVALVE LLC

Aortic transcatheter heart valve bioprosthesis, stent-like framework

• Primary Device ID: 00643169934115
• NIH Device Record Key: 5fd81c7c-ad08-40c7-9aab-070a9599072d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnVeo™ R
• Version Model Number: LS-MDT2-23-US
• Company DUNS: 079527231
• Company Name: MEDTRONIC COREVALVE LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: 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
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment
• Special Storage Condition, Specify: Between 0 and 0 *Store the catheter and LS in a cool, dry environment

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169934115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130021

FDA Product Code

• NPT: Aortic valve, prosthesis, percutaneously delivered

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: 2017-03-31

On-Brand Devices [EnVeo™ R]

• 00643169956193: DELIV SYS ENVEOR-N-US 34MM COMM
• 00643169934122: LOADING SYSTEM LS-MDT2-2629-US
• 00643169934115: LOADING SYSTEM LS-MDT2-23-US
• 00643169800939: DELIV SYS EnVeoR-N-US OREVAC 20Fr
• 00643169800915: DELIV SYS EnVeoR-US OREVAC 18Fr