ProMed ProM-094B

GUDID 00185098000917

4" Round Black Silicone Electrode (1 Pack = 2 Electrodes per Pack)

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00185098000917
• NIH Device Record Key: f8b018a9-8413-423e-ba22-03c31eeca48f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProMed
• Version Model Number: ProM-054B
• Catalog Number: ProM-094B
• Company DUNS: 135741127
• Company Name: PRO MEDICAL SUPPLIES, 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: false
• 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 Dimensions

• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch
• Circumference: 4 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00185098000917 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-01
• Device Publish Date: 2019-10-24

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• 10185098000860: (25) 3" Round Red Silicone Electrodes (25 Pack Per Inner Bag - 2 Electrodes Per Pack)