Duet®

GUDID 00613994445391

EDMS 46916 DUET BLUECORE WITH VCATH

MEDTRONIC PS MEDICAL, INC.

Ventricular cerebrospinal fluid drainage kit

• Primary Device ID: 00613994445391
• NIH Device Record Key: c29d7381-368f-4267-bc8c-5bf5be822ab3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duet®
• Version Model Number: 46916
• Company DUNS: 089055867
• Company Name: MEDTRONIC PS MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994445391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K984053

FDA Product Code

• PCB: External cerebrospinal fluid (CSF) diversion

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: 2015-07-16

On-Brand Devices [Duet®]

• 00613994445407: EDMS 46917 DUET INTERLINK WITH LCATH
• 00613994445391: EDMS 46916 DUET BLUECORE WITH VCATH
• 00613994445384: EDMS 46915 DUET INTERLINK WITH VCATH
• 00613994445377: EDMS 46914 DUET BLUECORE SITES
• 00613994445360: EDMS 46913 DUET INTERLINK SITES
• 20613994430537: BAG 46912 DRAINAGE DEHP-FREE 10PK
• 00613994430526: BAG 46911 DRAINAGE DEHP-FREE 1PK
• 00763000396008: EDMS DUET 46915 INTERLINK W VCATH
• 00763000431235: BAG 46911 DRAINAGE DEHP-FREE 1PK
• 00763000406028: EDMS 46917 DUET INTERLINK WITH LCATH
• 00763000406011: EDMS 46916 DUET BLUECORE WITH VCATH
• 00763000406004: EDMS 46913 DUET INTERLINK SITES
• 00763000395971: EDMS DUET 46914 SMARTSITE SITES
• 20763000431277: BAG 46912 DRAINAGE DEHP-FREE 10PK
• 00763000428785: EDMS 46917 DUET INTERLINK WITH LCATH
• 00763000428778: EDMS 46916 DUET BLUECORE WITH VCATH
• 00763000428761: EDMS DUET 46915 INTERLINK W VCATH
• 00763000428754: EDMS DUET 46914 SMARTSITE SITES
• 00763000428747: EDMS 46913 DUET INTERLINK SITES
• 00763000428730: BAG 46912 DRAINAGE DEHP-FREE 10PK
• 00763000428723: BAG 46911 DRAINAGE DEHP-FREE 1PK
• 00763000624804: EDMS 46917 DUET INTERLINK WITH LCATH
• 00763000624798: EDMS 46916 DUET BLUECORE WITH VCATH
• 00763000624781: EDMS DUET 46915 INTERLINK W VCATH
• 00763000624774: EDMS DUET 46914 SMARTSITE SITES
• 00763000624767: EDMS 46913 DUET INTERLINK SITES
• 00763000624750: BAG 46912 DRAINAGE DEHP-FREE 10PK
• 00763000624743: BAG 46911 DRAINAGE DEHP-FREE 1PK