Component Neuromonitoring System

GUDID B485CNSPTZ3101

Research model; optional camera that can be used to record video of the patient.

MOBERG RESEARCH INC

Multi-purpose digital medical camera

• Primary Device ID: B485CNSPTZ3101
• NIH Device Record Key: d6129acb-a324-4649-bd98-f947a6b2c42a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Component Neuromonitoring System
• Version Model Number: CNS-PTZ-310
• Company DUNS: 029957656
• Company Name: MOBERG RESEARCH INC
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B485CNSPTZ3101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080217

FDA Product Code

• MUD: Oximeter, Tissue Saturation

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: 2019-04-01
• Device Publish Date: 2019-03-22

On-Brand Devices [Component Neuromonitoring System]

• B485CNSPTZ3101: Research model; optional camera that can be used to record video of the patient.
• B485CNSPTZ3001: Domestic (U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSVID3201: International (non-U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSVID3101: Research model; optional camera that can be used to record video of the patient.
• B485CNSVID3001: Domestic (U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSINX3201: International (non-U.S.) model; 4 port isolated USB serial adapter
• B485CNSINX3101: Research model; 4 port isolated USB serial adapter
• B485CNSINX3001: Domestic (U.S.) model; 4 port isolated USB serial adapter
• B485CNSEEG3201: International (non-U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and
• B485CNSEEG3101: Research model; optional 40 input EEG amplifier for direct recording of EEG and other physiologi
• B485CNSEEG3001: Domestic (U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and other phy
• B485CNSEEG2201: International (non-U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and
• B485CNSEEG2101: Research model; optional 16 input EEG amplifier for direct recording of EEG and other physiologi
• B485CNSEEG2001: Domestic (U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and other phy
• B485CNS3201: International (non-U.S.) model; a portable, computer-based system that can continuously record,
• B485CNS3101: Research model; a portable, computer-based system that can continuously record, display, store a
• B485CNS3001: Domestic (U.S.) model; a portable, computer-based system that can continuously record, display,
• B485CNS3501: A portable, computer-based system that can continuously record, display, store and analyze physi