EasyNet

GUDID 00840067100479

EasyNet Movement

CADWELL INDUSTRIES, INC.

Electroencephalograph

• Primary Device ID: 00840067100479
• NIH Device Record Key: 80bc46fb-4809-41ab-8018-5ef171807b48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyNet
• Version Model Number: 190208-200
• 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: false
• 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(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com
• Phone: +1(800)245-3001
• Email: service@cadwell.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067100479 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K040986

FDA Product Code

• LEL: DEVICE, SLEEP ASSESSMENT

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-05

On-Brand Devices [EasyNet]

• 00840067100509: Multi Purpose
• 00840067100493: EasyNet SpO2
• 00840067100486: EasyNet Position
• 00840067100479: EasyNet Movement
• 00840067100462: EasyNet Nasal Pressure