CNAP® controller 21-FHCN-16706

GUDID 09120073930101

Unit

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073930101
• NIH Device Record Key: a182d57f-1b99-4bc9-95ae-864fc5cd6f78
• Commercial Distribution Discontinuation: 2019-11-18
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CNAP® controller
• Version Model Number: V4.1
• Catalog Number: 21-FHCN-16706
• Company DUNS: 303562672
• Company Name: CNSystems Medizintechnik AG
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4331672345633
• Email: service@cnsystems.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120073930101 [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: 2
• Public Version Date: 2019-11-20
• Device Publish Date: 2019-10-14

Devices Manufactured by CNSystems Medizintechnik AG

• 09120073930026 - AUX: Analog Out connector: 2019-11-20 Unit; connector for data analog output
• 09120073930033 - BP Wave Out: CNAP® transducer cable: 2019-11-20 Unit; grey; adapter to interface cable
• 09120073930040 - BP Wave Out: CNAP® transducer cable: 2019-11-20 Unit; black; adapter to interface cable
• 09120073930057 - BP Wave Out: CNAP® transducer cable: 2019-11-20 Unit; red; adapter to interface cable
• 09120073930064 - BP Wave Out: CNAP® transducer cable: 2019-11-20 Unit; yellow; adapter to interface cable
• 09120073930095 - CNAP® cable: 2019-11-20 Unit; 2.5m; interface 09120073930774 CNAP® controller to 09120073930750 CNAP® Monitor 500
• 09120073930118 - CNAP® controller set: 2019-11-20 SET of: 09120073930101, CNAP® controller 09120073930088, CNAP® controller clamp
• 09120073930125 - CNAP® double finger cuff "large": 2019-11-20 Unit; sensor with Extended Lifecycle (150h)