The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the…
The SG 066 Oxygen Enrichment Kit is designed for use on certain ventilators to provide higher concentrations of oxygen to the patient by mixing room air with an oxygen source at the proximal airway.
Who Else Makes It
Concentrated in Guangdong (4), Jiangsu (2), Fujian (1). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for SG 066 Oxygen Enrichment Kit | Listed by | Instrumentation Industries, Incorporated, United States |
| FDA product code | CBK |
| Device type | Ventilator, Continuous, Facility Use |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5895 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K992670 |
| Record published | 2015-10-24 |
| Record revised | 2021-09-16 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | High-level Disinfectant |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.