SUDOSCAN® ADSPHD
GUDID B122ADSPHD0
SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes Dock Smart Electrodes USB cable A software application
IMPETO MEDICAL
Skin electrical conductance meter| Primary Device ID | B122ADSPHD0 |
| NIH Device Record Key | 58bdcae8-49ee-4925-ac20-671c20002ed0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SUDOSCAN® |
| Version Model Number | SUDOSCAN S |
| Catalog Number | ADSPHD |
| Company DUNS | 279502673 |
| Company Name | IMPETO MEDICAL |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com | |
| Phone | (858) 450-2800 |
| sales_us@impeto-medical.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 65 Degrees Fahrenheit and 95 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 113 Degrees Fahrenheit |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B122ADSPHD0 [Primary] |
FDA Product Code
| GZO | Device, Galvanic Skin Response Measurement |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-06-07 |
| Device Publish Date | 2019-05-13 |
On-Brand Devices [SUDOSCAN®]
| B122S2MU0 | SUDOSCAN2 Master unit |
| B122DSP0 | Smart electrodes |
| B122APH20 | Hand electrodes standard |
| B122APF20 | Foot electrodes standard |
| B122ADSPHD0 | SUDOSCAN S device consists of the following Hand Smart Electrodes Dock Foot Smart Electrodes D |
Trademark Results [SUDOSCAN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SUDOSCAN 79100037 4181325 Live/Registered |
IMPETO MEDICAL 2011-05-25 |
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