Easy Ambulatory

GUDID 00840067100585

Q-Video Mobile 2

CADWELL INDUSTRIES, INC.

Electroencephalograph

• Primary Device ID: 00840067100585
• NIH Device Record Key: cac6a49e-8629-4294-903c-2802eb11c183
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Easy Ambulatory
• Version Model Number: 190293-200
• Company DUNS: 098554157
• Company Name: CADWELL INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com
• Phone: +1(509)735-6481
• Email: applications@cadwell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067100585 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133355

FDA Product Code

• GWE: Stimulator, photic, evoked response

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-14
• Device Publish Date: 2016-09-05

On-Brand Devices [Easy Ambulatory]

• 00840067100660: Easynet Ambulatory Microphone
• 00840067100592: 32 Ch EEG EasyNet Amplifier
• 00840067100585: Q-Video Mobile 2
• 00840067100455: Easy Ambulatory Recorder