| Primary Device ID | 00718175003244 |
| NIH Device Record Key | 44b0bf87-9d2f-4ac7-b307-15461970be51 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aerotech I Radioaerosol Administration System |
| Version Model Number | 177-324 |
| Catalog Number | 177-324 |
| Company DUNS | 043833813 |
| Company Name | BIODEX MEDICAL SYSTEMS, INC. |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00718175003244 [Primary] |
| GS1 | 10718175003258 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 20718175003262 [Package] Package: Box [10 Units] In Commercial Distribution |
| GS1 | 30718175003276 [Package] Package: Box [25 Units] In Commercial Distribution |
| CAF | Nebulizer (Direct Patient Interface) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-09-06 |
| Device Publish Date | 2017-12-18 |
| 00718175003244 | AeroTech I Convenience Kit with small particle delivery system |
| 00718175001240 | Aerotech I Radioaerosol Administration System |
| 00718175087633 | AeroTech I Shield |