CNAP® cable 20-FEKA-10041

GUDID 09120073931528

Unit; 2.5m; Primary DI Number valid for all versions of the cable

CNSystems Medizintechnik GmbH

Patient monitoring system module, blood pressure, noninvasive

• Primary Device ID: 09120073931528
• NIH Device Record Key: 40634641-2f2c-4108-b132-4a76c089770d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CNAP® cable
• Version Model Number: C
• Catalog Number: 20-FEKA-10041
• Company DUNS: 300526077
• Company Name: CNSystems Medizintechnik GmbH
• 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: 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	09120073931528 [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: 2020-03-10
• Device Publish Date: 2018-11-28

Devices Manufactured by CNSystems Medizintechnik GmbH

• 09120073933027 - CNAP® Monitor 500 HD: 2024-07-18 Main Unit
• 09120073931962 - Set of electrodes: 2023-12-18 Set of 4ECG electrodes, 3 ICG electrodes and one grounding pad
• 09120073932273 - TFC NBP Cuff SMALL: 2023-10-26
• 09120073932280 - TFC NBP Cuff MEDIUM: 2023-10-26
• 09120073932297 - TFC NBP Cuff LARGE: 2023-10-26
• 09120073932303 - TFC NBP Cuff X-LARGE: 2023-10-26
• 09120073932327 - TFC CNAP Classic Adapter: 2023-10-26
• 09120073932334 - TFC Forearm Controller: 2023-10-26