| Primary Device ID | 07290019255109 |
| NIH Device Record Key | c06cedbc-387d-4724-b868-56216b2f4b70 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Scentific Test Kit |
| Version Model Number | 1 |
| Catalog Number | 02U111000 |
| Company DUNS | 532387650 |
| Company Name | APPSCENT MEDICAL LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Handling Environment Atmospheric Pressure | Between 77 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 77 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 77 KiloPascal and 101 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 5 Degrees Celsius and 35 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 77 KiloPascal and 101 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290019255109 [Primary] |
| NRK | Kit, Test, Olfactory |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-24 |
| Device Publish Date | 2026-02-16 |
| 07290019255055 - SCENTIFIC Respiratory Biofeedback | 2026-02-24 SCENTIFIC Respiratory Biofeedback is an instrument that provides a visual signal corresponding to the status of respiration, gui |
| 07290019255109 - Scentific Test Kit | 2026-02-24The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are presented to the patient's nose to subjectively assess the patient's ability to perceive scents. |
| 07290019255109 - Scentific Test Kit | 2026-02-24 The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are present |