CNAP® Monitor 500 21-FHCN-15511

GUDID 09120073930385

Main Unit; include quick Guide

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073930385
• NIH Device Record Key: 724d1349-c9d1-403b-a1d8-50d5c5890b33
• Commercial Distribution Discontinuation: 2019-11-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CNAP® Monitor 500
• Version Model Number: V1.5
• Catalog Number: 21-FHCN-15511
• Company DUNS: 303562672
• Company Name: CNSystems Medizintechnik AG
• Device Count: 1
• DM Exempt: true
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: +4331672345633
• Email: service@cnsystems.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 64.7 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120073930385 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082599

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-20
• Device Publish Date: 2017-08-02

On-Brand Devices [CNAP® Monitor 500 ]

• 09120073931139: SET of: 09120073931146, CNAP® Monitor 500 HD, Main Unit including quick Guide 09120073930118,
• 09120073931122: SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNA
• 09120073931115: SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNA
• 09120073930972: SET of: 09120073930934, CNAP® Monitor 500, Main Unit including quick Guide 09120073930958, CNA
• 09120073930934: Main Unit; include quick Guide
• 09120073930385: Main Unit; include quick Guide