Tru

GUDID 00853177007040

Tru™ Foam-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: 00853177007040
• NIH Device Record Key: 148b3ed1-8f59-4a1f-b6cc-ea2c5c492ade
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tru
• Version Model Number: 710281-001
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit
• Storage Environment Temperature: Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853177007040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130987

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 [Tru]

• 00853177007071: Tru™ Foam-Backed Reusable Electrode, 2" x 4" Rectangle 4/Pkg.
• 00853177007064: Tru™ Foam-Backed Reusable Electrode, 2.75" Round 4/Pkg.
• 00853177007057: Tru™ Foam-Backed Reusable Electrode, 2" x 2" Square 4/Pkg.
• 00853177007040: Tru™ Foam-Backed Reusable Electrode, 2" Round 4/Pkg.
• 00853177007033: Tru™ Cloth-Backed Reusable Electrode, 2" x 4" Rectangle 4/Pkg.
• 00853177007026: Tru™ Cloth-Backed Reusable Electrode, 2.75" Round 4/Pkg.
• 00853177007019: Tru™ Cloth-Backed Reusable Electrode, 2" x 2" Square 4/Pkg.
• 00853177007002: Tru™ Cloth-Backed Reusable Electrode, 2" Round 4/Pkg.