Primary Device ID | 04710953421604 |
NIH Device Record Key | 9b5b2682-d74c-41d0-b41c-9eea079d12ef |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TekCare Non-Contact Infrared Thermometer |
Version Model Number | NT19 |
Company DUNS | 658023275 |
Company Name | AVITA CORPORATION |
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 | 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 | true |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 16 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 16 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Storage Environment Temperature | Between -25 Degrees Celsius and 55 Degrees Celsius |
Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
Handling Environment Temperature | Between 16 Degrees Celsius and 40 Degrees Celsius |
Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |