CNAP® double finger cuff "medium" 20-FVMA-15520U

GUDID 09120073930194

Unit, with Unlimited Lifecycle (600h)

CNSystems Medizintechnik AG

Noninvasive haemodynamic monitoring system

• Primary Device ID: 09120073930194
• NIH Device Record Key: 3b74cfff-39c2-4a28-aaca-b7e4049d3cf4
• Commercial Distribution Discontinuation: 2019-11-19
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: CNAP® double finger cuff "medium"
• Version Model Number: V4.4
• Catalog Number: 20-FVMA-15520U
• 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.at

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120073930194 [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 "medium"]

• 09120073930194: Unit, with Unlimited Lifecycle (600h)
• 09120073930187: Unit, with Standard Lifecycle (75h)
• 09120073930170: Unit, with Maximum Lifecycle (300h)
• 09120073930163: Unit; sensor with Extended Lifecycle (150h)