Electrodes

GUDID 10817377021401

Chin Electrode Patch

DYMEDIX DIAGNOSTICS, INC.

Polysomnograph

• Primary Device ID: 10817377021401
• NIH Device Record Key: b7614720-32c5-4ddf-8e13-870f122e7547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electrodes
• Version Model Number: 13-30000-0001
• Company DUNS: 079976463
• Company Name: DYMEDIX DIAGNOSTICS, 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817377021404 [Primary]
GS1	10817377021401 [Package]; Contains: 00817377021404; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020468

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-10-11

On-Brand Devices [Electrodes]

• 10817377021418: Dual EMG Electrode
• 10817377021401: Chin Electrode Patch
• 10817377021395: Dual Snap Lead Wire, 60", 2 Pack
• 10817377021388: Dual Snap Lead Wire, 48", 2 Pack
• 10817377021371: Dual Snap Lead Wire, 120", 2 Pack
• 10817377021364: Dual Snap Lead Wire, 100", 2 Pack
• 10817377023115: XM Movement Sensor
• 10817377023108: Chin Electrode Patch Infant
• 10817377022835: Dual Wired EMG Electrode 60"
• 10817377022828: Dual Wired EMG Electrode 120"