Mediflex

GUDID 00853177007088

Mediflex™ Cloth-Backed Reusable Electrode, 2" Round 4/Pkg.

TRUMEDICAL SOLUTIONS, LLC

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: 00853177007088
• NIH Device Record Key: 14a2f605-a782-4684-9a40-5779563fde95
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mediflex
• Version Model Number: 710582-001
• Company DUNS: 832979079
• Company Name: TRUMEDICAL SOLUTIONS, LLC
• 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: 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: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com
• Phone: 423-910-0100
• Email: customerservice@tru-medical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853177007088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160138

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: 2016-10-25

On-Brand Devices [Mediflex]

• 00853177007156: Mediflex™ Foam-Backed Reusable Electrode, 2" x 3.5" Rectangle 4/Pkg.
• 00853177007149: Mediflex™ Foam-Backed Reusable Electrode, 2.75" Round 4/Pkg.
• 00853177007132: Mediflex™ Foam-Backed Reusable Electrode, 2" x 2" Square 4/Pkg.
• 00853177007125: Mediflex™ Foam-Backed Reusable Electrode, 2" Round 4/Pkg.
• 00853177007118: Mediflex™ Cloth-Backed Reusable Electrode, 2" x 3.5" Rectangle 4/Pkg.
• 00853177007101: Mediflex™ Cloth-Backed Reusable Electrode, 2.75" Round 4/Pkg.
• 00853177007095: Mediflex™ Cloth-Backed Reusable Electrode, 2" x 2" Square 4/Pkg.
• 00853177007088: Mediflex™ Cloth-Backed Reusable Electrode, 2" Round 4/Pkg.