Embla 021919

GUDID 00382830047234

NATUS EMBLA NDx

XLTEK

Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph Electroencephalograph

• Primary Device ID: 00382830047234
• NIH Device Record Key: 673aa2ed-b964-474a-aab2-872ba951e541
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Embla
• Version Model Number: 021919
• Catalog Number: 021919
• Company DUNS: 245258280
• Company Name: XLTEK
• 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

Customer Support Contacts

• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com
• Phone: 905-829-5300
• Email: OTS@natus.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382830047234 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180290

FDA Product Code

• GWQ: Full-Montage Standard 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: 2018-08-13
• Device Publish Date: 2018-07-13

On-Brand Devices [Embla]

• 00382830047241: NATUS EMBLA SDx
• 00382830047234: NATUS EMBLA NDx