ProPatch ProM-010

GUDID 00185098000078

Electrodes White Foam Back 1.5"x1.5" (1 pack with 4 electrodes)

PRO MEDICAL SUPPLIES, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: 00185098000078
• NIH Device Record Key: ada52a60-5004-4cd4-9cbb-fb38cbbd15a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProPatch
• Version Model Number: ProM-010
• Catalog Number: ProM-010
• 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	00185098000078 [Primary]
GS1	18509800007804 [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: 2016-06-27

On-Brand Devices [ProPatch]

• 00185098000443: Electrodes Tan Cloth 1.5"x13.75" (1 electrode per pack)
• 00185098000337: Electrodes Tan Cloth Back 2" Round (1 pack = 4 electrodes)
• 00185098000214: Electrodes Tan Cloth 2"x4" (1 pack = 4 electrodes per pack)
• 00185098000207: Electrodes Tan Cloth 2.0"x2.0" (1 pack = 4 electrodes per pack)
• 00185098000146: Electrodes White Foam Back 4"x6" Hourglass Shape (1 per pack)
• 00185098000139: Electrodes White Foam Back 2"x4" (1 pack = 4 electrodes per pack)
• 00185098000115: Electrodes White Foam Back 2" Round (1 pack = 4 electrodes)
• 00185098000092: Electrodes White Foam Back 2.0"x2.0" (1 Pack = 4 Electrodes Per Pack)
• 00185098000085: Electrodes Tan Cloth 3" Round (1 pack = 4 electrodes per pack)
• 00185098000078: Electrodes White Foam Back 1.5"x1.5" (1 pack with 4 electrodes)
• 30785098000116: Electrodes White Foam Back 2" Round (400 Packs Per Case - 4 Electrodes Per Pack = 1600)
• 30185098000130: Electrodes White Foam Back 2"x4" (200 packs per case- 4 electrodes per pack = 800)
• 30185098000093: Electrodes White Foam Back 2.0"x2.0" (400 packs per case - 4 electrodes per pack = 1600 pieces)
• 30185098000086: Electrodes Tan Cloth 3" Round (200 packs per case- 4 electrodes per pack = 800)
• 30185098000079: Electrodes White Foam Back 1.5"x1.5" (400 packs per case - 4 electrodes per pack = 1600 Pieces)
• 20185098000447: Electrodes Tan Cloth 1.75"x13.75" (400 electrodes per case - 1 electrode per pack = 400)
• 20185098000331: Electrodes Tan Cloth 2" Round (400 Packs Per Case - 4 Electrodes Per Case = 1600)
• 20185098000218: Electrodes Tan Cloth 2"x4" (200 packs per case - 4 electrodes per pack = 800)
• 20185098000201: Electrodes Tan Cloth Back 2.0" x 2.0" (400 packs per case - 4 electrodes per pack = 1600 pieces)
• 20185098000140: Electrodes White Foam Back 4"x6" Hourglass Shape (400 per case)
• 20185098000133: Electrodes White Foam Back 2"x4" (50 packs per box-4 electrodes per pack = 200)
• 20185098000119: Electrodes White Foam Back 2" Round (100 Packs Per Box - 4 Electrodes Per Pack =400 electrodes)
• 20185098000096: Electrodes White Foam Back 2.0"x2.0" Electrodes (100 packs per box -4 electrodes per pack = 400)
• 20185098000072: Electrodes White Foam Back 1.5"x1.5" (100 Packs Per Box - 4 Electrodes Per Pack = 400)
• 10185098000440: Electrodes Tan Cloth 1.5"x13.75" (100 electrodes per box)
• 10185098000334: Electrodes Tan Cloth 2" Round (100 packs per box- 4 electrodes per pack = 400)
• 10185098000211: Electrodes Tan Cloth 2"x4" (50 packs per box - 4 electrodes per pack = 200)
• 10185098000204: Electrodes Tan Cloth Back 2.0" x 2.0" (100 packs per box - 4 electrodes per pack = 400)
• 10185098000143: Electrodes White Foam Back 4"x6" Hourglass Shape (100 per box)
• 02085098000089: Electrodes Tan Cloth 3" Round (50 packs per box - 4 electrodes per pack = 200)