IOMAX Extender Pod

GUDID 00840067102657

TCS-9 Output Extender

CADWELL INDUSTRIES, INC.

Electromyograph

• Primary Device ID: 00840067102657
• NIH Device Record Key: 12711f17-c695-40ac-a3ae-ebede1ce8e37
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IOMAX Extender Pod
• Version Model Number: 362068-000
• 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: true
• 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(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	00840067102657 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162199

FDA Product Code

• GWE: Stimulator, photic, evoked response

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: 2019-05-21
• Device Publish Date: 2019-05-13

On-Brand Devices [IOMAX Extender Pod]

• 00840067102671: 16 Channel Input Extender
• 00840067102657: TCS-9 Output Extender