TFC Forearm Controller

GUDID 09120073932334

CNSystems Medizintechnik GmbH

Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation Multiparameter physiologic analysis workstation

• Primary Device ID: 09120073932334
• NIH Device Record Key: ee9e8574-6424-4b88-99bf-e89900f8ac48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TFC Forearm Controller
• Version Model Number: V4.x.y
• Company DUNS: 300526077
• Company Name: CNSystems Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120073932334 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223332

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-26
• Device Publish Date: 2023-10-18

Devices Manufactured by CNSystems Medizintechnik GmbH

• 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
• 09120073932334 - TFC Forearm Controller: 2023-10-26
• 09120073932341 - TFC Forearm Controller Clamp: 2023-10-26