CNS Envision

GUDID B485CNSENV1000

Software for use in the review, annotation and analysis of patient data collected using external physiological monitors.

NATUS NEUROLOGY INCORPORATED

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• Primary Device ID: B485CNSENV1000
• NIH Device Record Key: 56eb7828-af02-4618-ab72-729330a1918b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CNS Envision
• Version Model Number: 1.03.00
• Company DUNS: 874257488
• Company Name: NATUS NEUROLOGY INCORPORATED
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B485CNSENV1000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192572

FDA Product Code

• ORT: Burst Suppression Detection Software For Electroencephalograph

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: 2023-08-28
• Device Publish Date: 2023-08-18

Devices Manufactured by NATUS NEUROLOGY INCORPORATED

• 00382830059343 - Natus: 2024-04-15 UB4 Cart Grounding Kit
• 00382830059381 - Natus: 2024-04-15 1.8m Cable for HB6 or HB7 (6 ft)
• 00382830059411 - Natus: 2024-04-15 5.5m CBL for Nicolet Head Boxes (18 ft)
• 00382830059428 - Natus: 2024-04-15 6.1m Cable for ECR16 Amplifier (20 ft)
• 00382830059435 - Natus: 2024-04-15 4.5m Cable for ECR16 Head Box (15 ft)
• 00382830059442 - Natus: 2024-04-15 UB4 Cart
• 00382830061643 - Natus: 2024-04-15 WR50 Comfort Plus Probe Kit
• 00382830061650 - Natus: 2024-04-15 RS10 Comfort Probe Kit