NAMIC

GUDID H965905000501

PALESTRANT IRRIGATION & DRAINAGE SET

NAVILYST MEDICAL, INC.

Intravenous administration set

• Primary Device ID: H965905000501
• NIH Device Record Key: e0fb3f85-1678-4907-bdde-9d14bd67693c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NAMIC
• Version Model Number: 90500050
• Company DUNS: 809699023
• Company Name: NAVILYST 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H965905000500 [Primary]
HIBCC	H965905000501 [Package]; Contains: H965905000500; Package: BOX [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896087

FDA Product Code

• KGZ: ACCESSORIES, CATHETER

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: 2019-12-11
• Device Publish Date: 2016-09-20

On-Brand Devices [NAMIC]

• H965PK61102141S1: NAMIC Convenience Kit
• H965601600750: NAMIC Convenience Kit
• H965600911311: NAMIC Convenience Kit
• H965PK161337S1: NAMIC Convenience Kit
• H965920314831: clearaCIL Contrast Injection Line
• H965920314821: clearaCIL Contrast Injection Line
• H965920313031: clearaCIL Contrast Injection Line
• H965920313021: clearaCIL Contrast Injection Line
• H965920312031: clearaCIL Contrast Injection Line
• H965920312021: clearaCIL Contrast Injection Line
• H965920311031: clearaCIL Contrast Injection Line
• H965920311021: clearaCIL Contrast Injection Line
• H965913013031: NAMIC Standard Angiographic Kit with 3 Valve Manifold, On Handles
• H965913013011: NAMIC Standard Angiographic Kit with 3 Valve Manifold, Off Handles
• H965910314831: clearaCIL Contrast Injection Line
• H965910314821: clearaCIL Contrast Injection Line
• H965910313031: clearaCIL Contrast Injection Line
• H965910313021: clearaCIL Contrast Injection Line
• H965910312031: clearaCIL Contrast Injection Line
• H965910312021: clearaCIL Contrast Injection Line
• H965910311031: clearaCIL Contrast Injection Line
• H965910311021: clearaCIL Contrast Injection Line
• H965829000411: NAMIC Color Code Labels
• H965807510041: NAMIC Male Vented Threaded Port Protector
• H965807510031: NAMIC Male-Female Vented Port Protector
• H965807510001: NAMIC Male Non Vented Threaded Port Protector
• H965807500001: NAMIC Male Non Vented Threaded Port Protector
• H965807052021: NAMIC 2.5" Adaptor Tubing Connector, Male to Male Luer Lock
• H965806428421: NAMIC 84" Pressure Monitoring Line, Male to Male Luer Lock
• H965806427221: NAMIC 72" Pressure Monitoring Line, Male to Male Luer Lock
• H965806426021: NAMIC 60" Pressure Monitoring Line Male to Male Luer Lock
• H965806424821: NAMIC 48" Pressure Monitoring Line, Male to Male Luer Lock
• H965806423621: NAMIC 36" Pressure Monitoring Line Male to Male Luer Lock
• H965806422421: NAMIC 24" Pressure Monitoring Line, Male to Male Luer Lock
• H965806421221: NAMIC 12" Pressure Monitoring Line, Male to Male Luer Lock
• H965806419621: NAMIC 96" Pressure Monitoring Line, Female to Male Luer Lock
• H965806418421: NAMIC 84" Pressure Monitoring Line, Female to Male Luer Lock
• H965806417221: NAMIC 72" Pressure Monitoring Line, Female to Male Luer Lock
• H965806416021: NAMIC 60" Pressure Monitoring Line, Femal to Male Luer Lock
• H965806414821: NAMIC 48" Pressure Monitoring Line, Female to Male Luer Lock
• H965806413621: NAMIC 36" Pressure Monitoring Line, Female to Male Luer Lock
• H965806412421: NAMIC 24" Pressure Monitoring Line, Female to Male Luer Lock
• H965806411221: NAMIC 12" Pressure Monitoring Line, Female to Male Luer Lock
• H965806410621: NAMIC 6" Pressure Monitoring Line, Female to Male Luer Lock
• H965806227221: NAMIC 72" Pediatric Pressure Monitoring Line, Male to Male Luer Lock
• H965806224821: NAMIC 48" Pediatric Pressure Monitoring Line, Male to Male Luer Lock
• H965806223621: NAMIC 36" Pediatric Pressure Monitoring Line, Male to Male Luer Lock
• H965806222421: NAMIC 24" Pediatric Pressure Monitoring Line, Male to Male Luer Lock
• H965806221221: NAMIC 12" Pediatric Pressure Monitoring Line, Male to Male Luer Lock
• H965806220621: NAMIC 6" Pediatric Pressure Monitoring Line, Male to Male Luer Lock