StimPatch Stim-021

GUDID 00185098000719

Electrodes White Cloth 2.0"x2.0" (1 pack = 4 electrodes)

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00185098000719
• NIH Device Record Key: 78def145-38cb-44c4-95fc-b96cfee9e616
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimPatch
• Version Model Number: Stim-021
• Catalog Number: Stim-021
• Company DUNS: 135741127
• Company Name: PRO MEDICAL SUPPLIES, INC.
• Device Count: 4
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00185098000719 [Primary]
GS1	18509800071904 [Unit of Use]

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 [StimPatch]

• 00185098000740: Electrodes White Foam Back 2.0"x4.0" (1 Pack = 4 Electrodes)
• 00185098000733: Electrodes White Foam Back 2.0" Round (1 pack = 4 electrodes)
• 00185098000726: Electrodes White Foam Back 2.0"x2.0" (1 pack = 4 electrodes per pack)
• 00185098000719: Electrodes White Cloth 2.0"x2.0" (1 pack = 4 electrodes)
• 20185098000744: Electrodes White Foam Back 2.0"x4.0" (400 Packs Per Case-4 Electrodes Per Pack = 1600)
• 20185098000737: Electrodes White Foam Back 2.0" Round (400 Packs Per Case-4 Electrodes Per Pack = 1600)
• 20185098000720: Electrodes White Foam Back 2.0"x2.0" (400 Pack Per Case- 4 Electrodes Per Pack = 1600)
• 20185098000713: Electrodes White Cloth 2.0"x2.0" (400 Packs Per Box - 4 Electrodes Per Pack = 1600)
• 10185098000747: Electrodes White Foam Back 2.0"x4.0" (100 Packs Per Pack = 4 Electrodes Per Pack = 400)
• 10185098000730: Electrodes White Foam Back 2.0" Round (100 Packs Per Box - 4 Electrodes Per Pack = 400)
• 10185098000723: Electrodes White Foam Back 2.0"x2.0" (100 Packs Per Box - 4 Electrodes Per Pack = 400)
• 10185098000716: Electrodes White Cloth 2.0"x2.0" (100 Packs Per Box - 4 Electrodes Per Pack = 400)