| Primary Device ID | 04710953421321 |
| NIH Device Record Key | ef7d745c-4e61-4bad-841f-22428149acfe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TekCare Infrared Thermometer |
| Version Model Number | TS46 |
| 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 Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04710953421314 [Primary] |
| GS1 | 04710953421321 [Package] Contains: 04710953421314 Package: [40 Units] In Commercial Distribution |
| FLL | Thermometer, Electronic, Clinical |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-31 |
| Device Publish Date | 2018-12-31 |
| 04710953421635 - Harbor Freight Tools | 2020-10-21 The product automatically measures human begins Systolic, Diastolic blood pressure and pulse rate by oscillometric method. The m |
| 04710953421604 - TekCare Non-Contact Infrared Thermometer | 2020-05-25 The NT19 thermometer is designed for the intermittent measurement of the human body's temperature in the domestic environment an |
| 04710953421529 - TekCare Touch Free Infrared Thermometer | 2020-04-23 The NT17 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in the domesti |
| 04710953421468 - TekCare Green-Type Infrared Thermometer | 2019-12-09 The IR Thermometer is intended to be used as the intermittent measurement of human body temperature for people of all ages. |
| 04710953420942 - Blood pressure monitor | 2019-11-08 The device is a wrist type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and |
| 04710953421161 - Blood pressure monitor | 2019-11-08 The device is a arm type blood pressure monitor intended for automatically measures systolic and diastolic blood pressure and pu |
| 04710953421345 - TekCare Blood Pressure Monitor | 2019-11-08 BPM19 Series Blood Pressure Monitor applies the Oscillometric method to measure human systolic / diastolic blood pressure and he |
| 04710953421307 - TekCare Touch Free Infrared Thermometer | 2019-01-31 The NT11 THERMO DISTANCE thermometer is designed for the intermittent measurement of the human body's temperature in a domestic |