GUDID 00673978228471

RES 44513 CSF-LUMBOPERITONEAL RES 20MM

MEDTRONIC PS MEDICAL, INC.

Lumboperitoneal shunt valve/reservoir

• Primary Device ID: 00673978228471
• NIH Device Record Key: 943018f1-61c7-4f27-aef3-fc13d7eb716d
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 44513
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, 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
• 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	00673978228471 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K831396

FDA Product Code

• JXG: Shunt, central nervous system and components

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: 2015-07-10

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

• 00763000950941 - Duet EDMS: 2025-03-31 EDMS 46913 DUET INTERLINK SITES/US
• 00763000950972 - Duet EDMS: 2025-03-31 EDMS 46914 DUET BLUECORE SITES/US
• 00763000281243 - Exacta Pole Clamp with laser level: 2025-02-25 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000281229 - Exacta Pole Clamp with laser level: 2025-02-24 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413255 - Exacta™: 2025-02-10 ASSY 46711 EXACTA POLE CLAMP W/LASER
• 00763000413262 - Exacta™: 2025-02-10 CLAMP 46715 EXACTA PL NEG 25CM W/LSR
• 00763000422653 - Valve, StrataMR II, Regular: 2025-01-31 ASSY 46965MR SHUNT STRATAMR II REG CE
• 00763000422677 - Snap Shunt Assembly, StrataMR II, Regular: 2025-01-31 SHUNT 46966MR SNP ASSY STRATAMRII REG CE