Olympic CFM 200249-507, 62050, 62051

GUDID 00382830004053

Neonatal EEG Hydrogel sensor

NATUS MEDICAL INCORPORATED

Analytical scalp electrode, single-use

• Primary Device ID: 00382830004053
• NIH Device Record Key: b751f9b8-407e-4c16-8091-aedba87725a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Olympic CFM
• Version Model Number: Electrode Hydrogel
• Catalog Number: 200249-507, 62050, 62051
• Company DUNS: 962519208
• Company Name: NATUS MEDICAL 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	00382830004053 [Package]; Contains: 00382830053839; Package: [100 Units]; In Commercial Distribution
GS1	00382830053839 [Primary]

FDA Product Code

• OMA: Amplitude-Integrated 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: 2017-03-31

Devices Manufactured by NATUS MEDICAL INCORPORATED

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• 00382830050524 - NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER: 2024-11-08 NATUS LUMBAR EXTERNAL DRAINAGE CATHETHER
• 00382830050531 - NATUS LUMBAR CATHETER KIT: 2024-11-08 NATUS LUMBAR CATHETER KIT
• 00382830050548 - NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM WITH VENTRICULAR CATHETER
• 00382830050555 - NATUS EDS3 DRAINAGE SYSTEM: 2024-11-08 NATUS EDS3 DRAINAGE SYSTEM
• 00382830050562 - NATUS EDS3 COLLECT BAG KIT 5 BAGS: 2024-11-08 NATUS EDS3 COLLECT BAG KIT 5 BAGS
• 00382830050579 - NATUS EDS3 LEVELING DEVICE: 2024-11-08 NATUS EDS3 LEVELING DEVICE
• 00382830050593 - NATUS EDS3 LUMBAR CATHETER KIT: 2024-11-08 NATUS EDS3 LUMBAR CATHETER KIT