UltraStim X Blue

GUDID 00851913006326

AXELGAARD MANUFACTURING CO., LTD.

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: 00851913006326
• NIH Device Record Key: 6252fb0d-80d2-4532-8330-d983e4dd01dd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraStim X Blue
• Version Model Number: USXB50100
• 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: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com
• Phone: 760-451-8000
• Email: cs@axelgaard.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 80 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851913006326 [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: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [UltraStim X Blue]

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