EcoPatch Eco-021

GUDID 20185098000638

Electrodes White Cloth Back 2.0"x2.0" (400 Pack Per Box - 4 Electrodes Per Pack = 1600 )

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 20185098000638
• NIH Device Record Key: aa619c07-763e-4f69-ad4c-cae5e5fb0551
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EcoPatch
• Version Model Number: Eco-021
• Catalog Number: Eco-021
• Company DUNS: 135741127
• Company Name: PRO MEDICAL SUPPLIES, INC.
• Device Count: 1600
• 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: true
• 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: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com
• Phone: 215-938-0200
• Email: sales@promedspecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	18509800063416 [Unit of Use]
GS1	20185098000638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132998

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: 2016-07-26

On-Brand Devices [EcoPatch]

• 00185098000634: Electrodes White Cloth Back 2.0"x2.0" (1 Pack = 4 Electrodes )
• 00185098000429: Electrodes White Foam Back 2.0"x4.0" (1 Pack = 4 Electrodes)
• 00185098000375: Electrodes White Foam Back 2.0"x2.0" (1 pack = 4 electrodes)
• 20185098000638: Electrodes White Cloth Back 2.0"x2.0" (400 Pack Per Box - 4 Electrodes Per Pack = 1600 )
• 20185098000423: Electrodes White Foam Back 2.0"x4.0" (400 Packs Per Case-4 Electrodes Per Pack = 1600)
• 20185098000379: Electrodes White Foam Back 2.0"x2.0" (400 Packs Per Box-4 Electrodes Per Pack = 1600)
• 10185098000631: Electrodes White Cloth Back 2.0"x2.0" (100 Pack Per Box - 4 Electrodes Per Pack = 400 )
• 10185098000426: Electrodes White Foam Back 2.0"x4.0" (100 Pack Per Box - 4 Electrodes Per Pack = 400)
• 10185098000372: Electrodes White Foam Back 2.0"x2.0" (100 Packs Per Box-4 Electrodes Per Pack = 400)