UltraStim SBM1AC006

GUDID 03770018808338

Sublimed 50mm x 50mm

AXELGAARD MANUFACTURING CO., LTD.

Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 03770018808338
• NIH Device Record Key: f07c3f90-df7b-47c6-a284-3235b083f794
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UltraStim
• Version Model Number: actiTENS
• Catalog Number: SBM1AC006
• 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: false
• 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

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	03770018808338 [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: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by AXELGAARD MANUFACTURING CO., LTD.

• 00851913006401 - PALS X: 2024-12-20 PALS X 2" x 2" square
• 00851913006418 - PALS X: 2024-12-20 PALS X 2" x 4" rectangle
• 03770018808338 - UltraStim: 2024-11-05Sublimed 50mm x 50mm
• 03770018808338 - UltraStim: 2024-11-05 Sublimed 50mm x 50mm
• 00851913006364 - UltraStim Snap Derma: 2024-09-26
• 00851913006371 - UltraStim Snap Derma: 2024-09-26
• 00851913006388 - UltraStim X Derma: 2024-09-26
• 00851913006395 - UltraStim X Derma: 2024-09-26
• 00851913006241 - PALS CLINICAL: 2023-06-14 2" x 2" square