| Primary Device ID | 07290016675016 |
| NIH Device Record Key | 51e6f58a-dcb4-49fe-bee1-01ea1b89bea3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MiniBox+ |
| Version Model Number | MiniBox+ |
| Company DUNS | 514812275 |
| Company Name | PULMONE ADVANCED MEDICAL DEVICES LTD |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290016675016 [Primary] |
| BZG | Spirometer, Diagnostic |
| 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 | 2017-01-27 |
| 07290016675009 - MiniBox | 2018-07-06 The MiniBox is intended to measure lung function in adult and pediatric patients while at rest (including spirometry and lung vo |
| 07290016675016 - MiniBox+ | 2018-07-06The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (including spirometry, lun |
| 07290016675016 - MiniBox+ | 2018-07-06 The PulmOne MiniBox+ is intended to measure lung function in adult and pediatric patients, 5 years and older, while at rest (inc |