Grass` AS40-PLUS

GUDID 00382830022774

AS40-PLUS BASE SYSTEM

XLTEK

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

• Primary Device ID: 00382830022774
• NIH Device Record Key: e2620248-f160-4cf0-afb9-96b42f5aea2c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Grass`
• Version Model Number: AS40-PLUS
• Catalog Number: AS40-PLUS
• 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	00382830022774 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172711

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

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• 00382830061902 - Xltek: 2024-04-29 OBM Starter Kit
• 00382830047425 - Xltek: 2024-04-19 EEG32U
• 00382830057585 - Xltek: 2024-04-19 XactTrace Belt 65.6ft/20m
• 00382830058056 - Natus: 2024-04-10 EMU40EX Breakout Box
• 00382830061889 - ALGO Pro: 2024-04-05 ALGO Pro Newborn Hearing Screening Device