GUDID 10681490185162

POUCH 8590-1 SYNCHROMED PUMP US

MEDTRONIC, INC.

Implantable infusion pump mesh bag

• Primary Device ID: 10681490185162
• NIH Device Record Key: 664e5a65-82a2-480a-bfdf-973e523340e4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 8590-1
• Company DUNS: 006261481
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10681490185162 [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: 4
• Public Version Date: 2026-01-21
• Device Publish Date: 2014-09-23

Devices Manufactured by MEDTRONIC, INC.

• 00199150071883 - NA: 2026-03-09 CUSTOM PACK BB12T77R1 HLO ADLT TUBI
• 00763000936594 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-3-5
• 00763000936600 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-3-15
• 00763000936617 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-4-5 US
• 00763000936624 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-4-15
• 00763000936631 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-5-20
• 00763000936648 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-5-30
• 00763000936655 - Concerto Versa™: 2026-03-09 COIL CONCERTO VERSA CV-6-20