GUDID 00643169466821

CATH 43103 C/P CATH STANDARD BAR IMP

MEDTRONIC PS MEDICAL, INC.

Peritoneal/atrial cerebrospinal fluid catheter

• Primary Device ID: 00643169466821
• NIH Device Record Key: 42405607-73fe-4358-8893-1c6c72188e8e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 43103
• 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

Device Dimensions

• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter
• Outer Diameter: 2.5 Millimeter
• Length: 90 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169466821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K792005

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: 2015-07-08

Devices Manufactured by MEDTRONIC PS MEDICAL, INC.

• 00763000333461 - Exacta™: 2024-12-23 EDMS 27579 EXACTA W/ PATIENT LINE Y-PORT
• 00763000333478 - Exacta™: 2024-12-23 KIT 27581 EXACTA W/EDM VCATH 35CM
• 00763000333492 - Exacta™: 2024-12-23 EDM 27636 EXACTA W/BRAIDED CORD LOCK
• 00763000333508 - Exacta™: 2024-12-23 BAG 27654 EXACTA W/DRAINPORT GLUED ON
• 00763000333515 - Exacta™: 2024-12-23 EDM 27666 EXCTA W GLUE STPCK GR PT LN
• 00763000333560 - Exacta™: 2024-12-23 EDM 27732 EXACTA W/NDL-LS INJ. ST W/CAP
• 00763000333607 - Exacta™: 2024-12-23 EDMS 27785 EXACTA 50ML BC NDLESS INJ
• 00763000333614 - Exacta™: 2024-12-23 EDMS 27795 EXACTA 100ML CATH