INDURA®

GUDID 00613994586032

CATH 8711 2PC CLSD TIP JAPAN US (TRAY)

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable

• Primary Device ID: 00613994586032
• NIH Device Record Key: 470059de-5cdc-453b-bc04-a4df194e98cb
• Commercial Distribution Discontinuation: 2014-10-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: INDURA®
• Version Model Number: 8711
• Company DUNS: 796986144
• Company Name: MEDTRONIC, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994586032 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P860004

FDA Product Code

• LKK: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

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 [INDURA®]

• 00613994586056: CATH 8709SC 1PC SUTURLESS US (TRAY)
• 00613994586032: CATH 8711 2PC CLSD TIP JAPAN US (TRAY)