TECNIMED
GUDID 00182097000382
Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect bites.
TECNIMED SRL
Insect bite/sting electrical stimulator| Primary Device ID | 00182097000382 |
| NIH Device Record Key | eaf07fc9-8112-4c05-87f0-1f617ea52f3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TECNIMED |
| Version Model Number | Disc-o-Click |
| 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 Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00182097000368 [Primary] |
| GS1 | 00182097000382 [Package] Contains: 00182097000368 Package: carton box [3 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- deNovo: DEN130019
FDA Product Code
| OSG | Piezo-Electric Stimulator For Relief Of Mosquito Bite Itch |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-11-18 |
| Device Publish Date | 2018-05-15 |
On-Brand Devices [TECNIMED]
| 00182097000382 | Limited output transcutaneous piezoelectric stimulator for skin reactions associated with insect |
| 00182097000351 | Infrared thermometer intended for intermittent measurement of human body temperature in people o |
| 00182097000511 | Infrared non contact thermometer intended for the intermittent measurement of human body tempera |
Trademark Results [TECNIMED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TECNIMED 76165748 2751718 Live/Registered |
Tecnimed srl 2000-11-15 |
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