| Primary Device ID | 05060485270027 |
| NIH Device Record Key | b90e4cc6-fa08-4abb-a66d-bf0d17170885 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Acoustic Rhinometer |
| Version Model Number | A1 |
| Catalog Number | N/A |
| Company DUNS | 771009610 |
| Company Name | GM INSTRUMENTS LIMITED |
| 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 | 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 | false |
| Storage Environment Humidity | Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05060485270027 [Primary] |
| BXQ | Rhinoanemometer (Measurement Of Nasal Decongestion) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-19 |
| 05060485270034 - Rhinomanometer | 2018-07-06 An electronic device designed to calculate nasal resistance by measuring nasal airflow and the air pressure producing that flow |
| 05060485270027 - Acoustic Rhinometer | 2018-03-29A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of the nose to be recorded |
| 05060485270027 - Acoustic Rhinometer | 2018-03-29 A line powered (AC- powered), or powered via a connected computer, electronic device designed to allow the internal profile of t |