CNAP® double finger cuff "large" 20-FVMA-15620E

GUDID 09120073930125

Unit; sensor with Extended Lifecycle (150h)

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073930125
• NIH Device Record Key: 9a97278e-ee2d-47f6-a4aa-18c9fdae5fc7
• Commercial Distribution Discontinuation: 2019-11-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CNAP® double finger cuff "large"
• Version Model Number: V4.4
• Catalog Number: 20-FVMA-15620E
• 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: 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	09120073930125 [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

On-Brand Devices [CNAP® double finger cuff "large"]

• 09120073930156: Unit, with Unlimited Lifecycle (600h)
• 09120073930149: Unit, with Standard Lifecycle (75h)
• 09120073930132: Unit, with Maximum Lifecycle (300h)
• 09120073930125: Unit; sensor with Extended Lifecycle (150h)