ValuTrode
GUDID 00851913006289
2.0” x 2.0” (5cm x 5 cm) Square Neurostimulation Electrode featuring VELCRO® brand fasteners as the top cover. VELCRO® is a registered trademark of Velcro BVBA.
AXELGAARD MANUFACTURING CO., LTD.
Transcutaneous electrical stimulation electrode| Primary Device ID | 00851913006289 |
| NIH Device Record Key | 569fab0e-7d66-4498-baf2-781b919fe976 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ValuTrode |
| Version Model Number | 180-0040-00 |
| 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 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| customerservice@axelgaard.com | |
| Phone | (760)451-8004 |
| 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 | 00851913006289 [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 |
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 | 2024-11-05 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 |
Trademark Results [ValuTrode]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VALUTRODE 75272608 2179620 Live/Registered |
AXELGAARD MANUFACTURING COMPANY, LTD. 1997-04-10 |
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