NT8501202 NT8501202

GUDID 00382830056823

Pudenz Cardiac Catheter (High Pressure)

NATUS MEDICAL INCORPORATED

Atrial cerebrospinal fluid catheter

• Primary Device ID: 00382830056823
• NIH Device Record Key: 7ae01cc1-19cc-4ea3-a29a-287d1b4e8b78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NT8501202
• Version Model Number: NT8501202
• Catalog Number: NT8501202
• Company DUNS: 081325959
• Company Name: NATUS MEDICAL INCORPORATED
• 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: true
• Expiration Date: true
• 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: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com
• Phone: 1-800-356-0007
• Email: Madison.Helpdesk@Natus.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830056823 [Primary]
GS1	10381780072270 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153041

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-27
• Device Publish Date: 2020-04-17

Devices Manufactured by NATUS MEDICAL INCORPORATED

• 00382830050517 - NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET: 2024-11-08 NATUS EXTERNAL DRAINAGE VENTRICULAR CATHETER SET
• 00382830050524 - NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER: 2024-11-08 NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER
• 00382830050531 - NATUS LUMBAR CATHETER KIT: 2024-11-08 NATUS LUMBAR CATHETER KIT
• 00382830050548 - NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
• 00382830050555 - NATUS EDS3 DRAINAGE SYSTEM: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM
• 00382830050562 - NATUS EDS3 COLLECT BAG KIT 5 BAGS: 2024-11-08 NATUS EDS3 COLLECT BAG KIT 5 BAGS
• 00382830050579 - NATUS EDS3 LEVELING DEVICE: 2024-11-08 NATUS EDS3 LEVELING DEVICE
• 00382830050593 - NATUS EDS3 LUMBAR CATHETER KIT: 2024-11-08 NATUS EDS3 LUMBAR CATHETER KIT