CNAP® forearm fixing cuff 20-FEMA-05705

GUDID 09120073930354

Unit; for fixing CNAP® Controller

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073930354
• NIH Device Record Key: 8f460cd7-9657-43e4-a02e-01c375f4139f
• Commercial Distribution Discontinuation: 2019-11-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CNAP® forearm fixing cuff
• Version Model Number: V1.11
• Catalog Number: 20-FEMA-05705
• 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• 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	09120073930354 [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: 2016-10-27

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)