UltraStim X Blue

GUDID 00851913006234

AXELGAARD MANUFACTURING CO., LTD.

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: 00851913006234
• NIH Device Record Key: 34546cc4-d20c-4a19-9649-c52290348607
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraStim X Blue
• Version Model Number: USXPB5000
• Company DUNS: 150959401
• Company Name: AXELGAARD MANUFACTURING CO., LTD.
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.com
• Phone: (760)451-8004
• Email: customerservice@axelgaard.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	00851913006234 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-07
• Device Publish Date: 2018-08-07

On-Brand Devices [UltraStim X Blue]

• 00851913006234: USXPB5000
• 00851913006043: USXPB5010
• 00851913006036: USXPB5050
• 00851913006326: USXB50100
• 00851913006319: USXB5050