Zynex Medical Electrodes

GUDID 00852670007083

NM900, Electrodes, 2" Round, 1 set of 3 electrodes.

ZYNEX MEDICAL, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 00852670007083
• NIH Device Record Key: c082e439-58e7-484b-813d-ad1e7889b311
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zynex Medical Electrodes
• Version Model Number: 300038
• Company DUNS: 141582226
• Company Name: ZYNEX MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: 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: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852670007083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2018-11-01
• Device Publish Date: 2018-10-01

On-Brand Devices [Zynex Medical Electrodes]

• 00852670007113: Belt-Electrode Garment, Small/Medium
• 00852670007106: Belt-Electrode Garment, Large/Extra Large
• 00852670007090: Electrodes, 2” Square for LBG, 4pk
• 00852670007083: NM900, Electrodes, 2" Round, 1 set of 3 electrodes.
• 00852670007076: Electrode 2” Round , 4 per Package