Olympic CFM OBM00042

GUDID 00382830008068

Neonatal Hydrogel Sensors

NATUS NEUROLOGY INCORPORATED

Analytical scalp electrode, single-use

• Primary Device ID: 00382830008068
• NIH Device Record Key: e81441a7-7460-41e2-ae84-fe762a55a384
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympic CFM
• Version Model Number: Neonatal Sensors
• Catalog Number: OBM00042
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-303-0306
• Email: Technical_service@natus.com
• Phone: 1-800-303-0306
• Email: Technical_service@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830008068 [Primary]

FDA Product Code

• OMC: Reduced- Montage Standard Electroencephalograph

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-31

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