Paragon Super Stim Electrode 442522

GUDID 00866811000208

PARAGON REHAB SUPPLIES 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: 00866811000208
• NIH Device Record Key: bffdfa6e-193a-4e06-a1ab-330816fac5e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paragon Super Stim Electrode
• Version Model Number: 2" x 2" Cloth Electrodes
• Catalog Number: 442522
• Company DUNS: 080255394
• Company Name: PARAGON REHAB SUPPLIES 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: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.com
• Phone: 505-881-2390
• Email: Jennifer@paragonrehabsupplies.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	00866811000208 [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: 2016-07-13

Devices Manufactured by PARAGON REHAB SUPPLIES LLC

• 00866811000208 - Paragon Super Stim Electrode: 2018-07-06
• 00866811000208 - Paragon Super Stim Electrode: 2018-07-06
• 00866811000215 - Paragon Super Stim Electrodes: 2018-07-06
• 00866811000222 - Paragon Super Stim Electrodes: 2018-07-06
• 00866811000239 - Paragon Super Stim Electrodes: 2018-07-06