Cadwell Disposable Patient Starter Kit

GUDID 00840067101360

CADWELL INDUSTRIES, INC.

Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium Electrode conductive medium

• Primary Device ID: 00840067101360
• NIH Device Record Key: b323968d-c8ae-412d-beaa-f83d50ecda8e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cadwell Disposable Patient Starter Kit
• Version Model Number: 302221-200
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• 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
• 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 Dimensions

• Length: 30 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch
• Length: 18 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840067101360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933803

FDA Product Code

• GXY: ELECTRODE, CUTANEOUS

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: 2018-10-22
• Device Publish Date: 2016-09-05

Devices Manufactured by CADWELL INDUSTRIES, INC.

• 00840067102879 - Cadwell Guiardian: 2024-03-12 Power Comm
• 00840067102886 - Cadwell Guiardian: 2024-03-12 Base
• 00840067102893 - Cadwell Guiardian: 2024-03-12 24-Channel Omni Amplifier
• 00840067102909 - Cadwell Guiardian: 2024-03-12 ES-10 Electrical Stimulator
• 00840067102916 - Cadwell Guiardian: 2024-03-12 SMX-32 Direct Cortical Mapping
• 00840067103609 - Cadwell Guiardian: 2024-03-12 AVX Auditory and Visual Stimulator
• 10840067101411 - Cadwell Disposable Disc Electrodes: 2024-01-09
• 00840067103890 - Cadwell: 2022-10-03 Ring Electrode with 20in lead attached length