Cala Trio
GUDID 00851749007108
Base Station
CALA HEALTH, INC.
Tremor-suppression transcutaneous electrical stimulation wristband| Primary Device ID | 00851749007108 |
| NIH Device Record Key | 66fd43f9-be40-4446-b644-4909aa0bfc8a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cala Trio |
| Version Model Number | TLA-3140 |
| Company DUNS | 078877556 |
| Company Name | CALA HEALTH, INC. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Operating and Storage Conditions
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851749007108 [Primary] |
FDA Product Code
| QBC | External Upper Limb Tremor Stimulator |
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 | 2020-07-08 |
| Device Publish Date | 2020-06-30 |
On-Brand Devices [Cala Trio]
| 00851749007160 | Band L-L |
| 00851749007153 | Band L-R |
| 00851749007146 | Band M-L |
| 00851749007139 | Band M-R |
| 00851749007122 | Band S-L |
| 00851749007115 | Band S-R |
| 00851749007108 | Base Station |
| 00851749007092 | Stimulator |
| 00851749007269 | Band-02-L-R |
| 00851749007252 | Band-02-L-L |
| 00851749007245 | Band-02-M-R |
| 00851749007238 | Band-02-M-L |
| 00851749007221 | Band-02-S-R |
| 00851749007214 | Band-02-S-L |
| 00851749007276 | Base Station-02 |
| 00851749007337 | Trio Band-Large Left Final Assembly-Gen 3 |
| 00851749007320 | Trio Band-Large Right Final Assembly-Gen 3 |
| 00851749007313 | Trio Band-Medium Left Final Assembly-Gen 3 |
| 00851749007306 | Trio Band-Medium Right Final Assembly-Gen 3 |
| 00851749007290 | Trio Band-Small Right Final Assembly-Gen 3 |
| 00851749007283 | Trio Band-Small Left Final Assembly-Gen 3 |
Trademark Results [Cala Trio]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CALA TRIO 88249053 not registered Live/Pending |
Cala Health, Inc. 2019-01-03 |
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