| Primary Device ID | 07640142190370 |
| NIH Device Record Key | e99a461c-32dc-4cac-a557-ed934cc573cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EasyOne Pro LAB |
| Version Model Number | 3100-1 |
| Catalog Number | 3100-1 |
| Company DUNS | 487451916 |
| Company Name | NDD Medizintechnik AG |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +41444452530 |
| info@ndd.ch |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07640142190370 [Primary] |
| BTY | Calculator, Predicted Values, Pulmonary Function |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
| 07640142190677 - spirette m | 2023-07-03 |
| 07640142190479 - Spiro-SP TrueFlow Sensor | 2023-07-03 |
| 07640142190646 - spirette FA Pro/LAB | 2023-07-03 |
| 07640142190486 - spirette | 2023-06-30 |
| 07640142190516 - EasyOne FlowTube | 2023-06-30 |
| 07640142190462 - EasyOne FlowTube | 2023-06-30 |
| 07640142190561 - Filter Adapter SP | 2023-06-30 |
| 07640142190578 - Filter Adapter FT | 2023-06-30 |