Flex Plus ProM-022

GUDID 20185098000102

Electrodes Flex Plus 2.0" x 2.0" (100 pack per box - 4 electrodes per pack = 400 pieces)

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 20185098000102
• NIH Device Record Key: 30fafe93-686f-44d4-bb71-b780a0fa3584
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flex Plus
• Version Model Number: ProM-022
• Catalog Number: ProM-022
• Company DUNS: 135741127
• Company Name: PRO MEDICAL SUPPLIES, INC.
• Device Count: 400
• 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	18509800010840 [Unit of Use]
GS1	20185098000102 [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 [Flex Plus]

• 00185098000344: Electrodes Black 2.0"x4.0" (1 Pack = 4 Electrodes Per Pack)
• 00185098000108: Electrodes - Flex Plus -2.0" x 2.0" (1 pack = 4 electrodes per pack)
• 30185098000109: Electrodes Flex Plus 2.0"x2.0" (400 packs per case - 4 electrodes per pack = 1600 pieces)
• 20185098000102: Electrodes Flex Plus 2.0" x 2.0" (100 pack per box - 4 electrodes per pack = 400 pieces)
• 10185098000341: Electrodes Black Foam (50 Pack Per Box -4 Electrodes Per Pack = 200)