Hopkins Medical Products Thermofocus 01500A3
GUDID 00182097000139
Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages
TECNIMED SRL
Infrared patient thermometer, skin| Primary Device ID | 00182097000139 |
| NIH Device Record Key | 5ac12129-b248-4a8e-b757-6554857e2591 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hopkins Medical Products |
| Version Model Number | Touch-Free Thermometer |
| Catalog Number | Thermofocus 01500A3 |
| Company DUNS | 445878788 |
| Company Name | TECNIMED SRL |
| 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 | false |
| Manufacturing Date | false |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between -18 Degrees Celsius and 70 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00182097000139 [Primary] |
| GS1 | 00182097000146 [Package] Package: box [150 Units] In Commercial Distribution |
| GS1 | 00182097000306 [Package] Package: box [80 Units] In Commercial Distribution |
| GS1 | 00182097000450 [Package] Package: carton box [90 Units] In Commercial Distribution |
| GS1 | 00182097000641 [Package] Package: carton box [50 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072108
FDA Product Code
| FLL | Thermometer, Electronic, Clinical |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-06-10 |
| Device Publish Date | 2016-09-20 |
Devices Manufactured by TECNIMED SRL
| 00182097000696 - Tecnimed - Hammacher | 2021-01-28 Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages |
| 00182097000559 - TECNIMED - Medline Industries, Inc | 2020-08-19 Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages |
| 00182097000511 - Tecnimed | 2020-06-12 Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages |
| 00182097000474 - Tecnimed - BV Medical | 2020-04-21 Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages |
| 00182097000498 - TECNIMED - Hopkins Medical Products | 2020-04-21 Infrared non contact thermometer intended for the intermittent measurement of human body temperature in people of all ages |
| 00182097000023 - Tecnibrands | 2019-11-18 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. |
| 00182097000382 - TECNIMED | 2019-11-18 Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites. |
| 00182097000429 - Tecnimed - 3J MEDICAL SUPPLIES Inc | 2019-09-18 Infrared thermometer intended for intermittent measurement of human body temperature in people of all ages. Measurement site: fo |
Trademark Results [Hopkins Medical Products]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HOPKINS MEDICAL PRODUCTS 87850594 5678117 Live/Registered |
HOPKINS UNIFORM COMPANY 2018-03-26 |
 HOPKINS MEDICAL PRODUCTS 76695475 3912639 Dead/Cancelled |
HOPKINS UNIFORM COMPANY 2009-01-27 |
 HOPKINS MEDICAL PRODUCTS 76113305 not registered Dead/Abandoned |
Hopkins Uniform Company 2000-08-18 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.