CNAP® Monitor 500 21-FHCN-15527

GUDID 09120073931122

SET of: 09120073930385, CNAP® Monitor 500, Main Unit including quick Guide 09120073930118, CNAP® controller set, incl. 09120073930101, CNAP® Controller and 09120073930088, Fixture for CNAP® controller, adapter between 09120073930101 CNAP® Controller and 09120073930354 CNAP® forearm fixing cuff 09120073930354, CNAP® forearm fixing cuff, for fixing 09120073930101 CNAP® Controller 09120073930095, CNAP® cable, 2.5m; interface 09120073930101 CNAP® controller to 09120073930385 CNAP® Monitor 500 09120073930156, CNAP® double finger cuff "large", sensor with Unlimited Lifecycle (600h) 09120073930194, CNAP® double finger cuff "medium", sensor with Unlimited Lifecycle (600h) 09120073930231, CNAP® double finger cuff "small", sensor with Unlimited Lifecycle (600h) 09120073931030, AUX: Analog out connector, connector for data analog output 09120073930033, BP Wave Out: CNAP® transducer cable, Unit; grey; adapter to interface cable 09120073930293, Operator's Manual USA, 09120073930668, CNAP® Component Organizer Set for CNAP® Monitor, 09120073930798 CNAP® double finger cuff mounting bracket together with 09120073930781 CNAP® controller mounting bracket NBP cuffs: 10840935102236, All Purpose Cuff, General, Large Adult, 98-0099-08, 20-FMA-15450 10840935102168, All Purpose Cuff, General, Adult 98-0097-10, 20-FMA-15350 10840935102113, All Purpose Cuff, General, Small Adult, 98-0095-09, 20-FMA-15250 10840935102052, All Purpose Cuff, General, Child, 98-0093-06, 20-FMA-15150 Patient Hose, 3 Meter, Rectus Fittings, 98-0028-00, 20-FMA-05050 Power cord USA Standard, 20-HEKA-01017, primary cord to external mains adapter External mains adapter, Manufacturer: M+R Multitronik GmbH, Niels-Bohr-Ring 28, 23568 Lübeck, Germany, phone: +49 451 60 99 5 0, 2 pcs. Thermal paper, 20-HVZU-00258

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073931122
• NIH Device Record Key: d5d406c8-8227-4151-a813-1c7278d4956d
• 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-15527
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120073931122 [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: 2017-06-29

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