Cascade IOMAX Intraoperative Monitor

GUDID 00840067100646

Cascade IOMAX Limb Module

CADWELL INDUSTRIES, INC.

Neurophysiologic monitoring system

• Primary Device ID: 00840067100646
• NIH Device Record Key: b7e7a767-ab1b-40ba-a509-b4e4f2bdfe5c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cascade IOMAX Intraoperative Monitor
• Version Model Number: 190295-200
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067100646 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162199

FDA Product Code

• GWF: STIMULATOR, ELECTRICAL, 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: 5
• Public Version Date: 2019-04-15
• Device Publish Date: 2017-05-31

On-Brand Devices [Cascade IOMAX Intraoperative Monitor]

• 00840067100653: Cascade IOMAX Cortical Module
• 00840067100646: Cascade IOMAX Limb Module
• 00840067100639: Cascade IOMAX Base Module
• 00840067102718: IOMAX 3M VEP LED GOGGLES
• 00840067102763: IOMAX 32 Channel Amplifier
• 00840067102220: LCSwap IOMAX
• 00840067102053: Cascade IOMAX VEP LED Goggles