Rhythmlink International, LLC

GUDID 10816312023845

Disposable Deep EEG Cup Electrodes

RHYTHMLINK INTERNATIONAL, LLC

Analytical scalp electrode, single-use

• Primary Device ID: 10816312023845
• NIH Device Record Key: c4885ea2-3d72-486e-b2ff-8ea21d384173
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Rhythmlink International, LLC
• Version Model Number: DC1415
• Company DUNS: 126290993
• Company Name: RHYTHMLINK INTERNATIONAL, LLC
• Device Count: 14
• 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

Customer Support Contacts

• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx
• Phone: 8666333754
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816312023848 [Unit of Use]
GS1	10816312023845 [Primary]

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: 2
• Public Version Date: 2022-04-05
• Device Publish Date: 2019-08-05

On-Brand Devices [Rhythmlink International, LLC]

• 00816312024401: 23 Deep Cup Electrode Harness with multipin connector
• 10816312023845: Disposable Deep EEG Cup Electrodes
• 00816312026733: Concentric Needle Cable
• 10816312027195: 24 electrodes, 1.5m blue 13mm subdermal needles
• 00816312027488: 1 Bundle of 3 Quick Connect Arrays with 27 Deep Cups, 1.5m and 2 MR Sticky Pads, 2.5m