NATUS NEUROLOGY INCORPORATED

GUDID 00382830028066

CT+ II MAIN UNIT

NATUS NEUROLOGY INCORPORATED

Foetal Doppler system Foetal Doppler system

• Primary Device ID: 00382830028066
• NIH Device Record Key: 6e00f240-d3d1-440e-a379-6bd08a322394
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NATUS NEUROLOGY INCORPORATED
• Version Model Number: XLT009
• 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: false
• 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	00382830028066 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K942441

FDA Product Code

• JAF: Monitor, Ultrasonic, Nonfetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-21

On-Brand Devices [NATUS NEUROLOGY INCORPORATED]

• 00382830029322: RESPONSE UNIT ASSY, SYNERGY
• 00382830028066: CT+ II MAIN UNIT