The reusable BE 30-142 is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied…
The reusable BE 30-142 is designed for use with ventilators, anesthesia machines, resuscitators, and other systems where PEEP or CPAP is required. A threshold-like resistance is applied after active exhalation. The PEEP valve prevents the exhalation pressure from dropping below a pre-determined value. PEEP ranges are adjustable from 3 to 20cm of water. Maximum PEEP can vary +/-10%. Objectives of PEEP therapy: 1) increase functional residual capacity by maintaining a positive pressure throughout the ventilatory cycle – improves gas distribution, 2) aid in the prevention of atelectasis via aveolar stinting, 3) decrease in the inspired oxygen fraction (FiO2) is an advantage, 4) help in the stabilization of flail chest condition, and 5) monitor tidal volume by connecting a spirometer to the outlet port.
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for BE 30-142 | Listed by | Instrumentation Industries, Incorporated, United States |
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K963347 |
| Record published | 2017-02-13 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Sterilisation | High-level Disinfectant, Ethylene Oxide, Radiation Sterilization, Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| 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.