| Primary Device ID | 00841470108014 |
| NIH Device Record Key | ec19ac1e-97ae-46ed-a25a-7766aa8a645b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aero-Sat Mini |
| Version Model Number | 301-429 |
| Company DUNS | 154502934 |
| Company Name | ENGINEERED MEDICAL SYSTEMS INC |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 | 00841470108014 [Primary] |
| GS1 | 10841470108011 [Package] Package: [50 Units] In Commercial Distribution |
| BYD | Condenser, Heat And Moisture (Artificial Nose) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-19 |
| Device Publish Date | 2023-12-11 |
| 10841470111431 - APV- Adjustable PEEP Valve | 2024-06-17 |
| 10841470108356 - FENEM | 2023-12-20 |
| 10841470108370 - FENEM | 2023-12-20 |
| 10841470109988 - A-PEP | 2023-12-20 |
| 10841470111196 - DPM | 2023-12-20 |
| 10841470100220 - Bacterial/Viral Filter | 2023-12-19 |
| 00841470100230 - Pulmonary Function Filter | 2023-12-19 |
| 10841470100985 - Aero-Pro | 2023-12-19 |