The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec Handi Oxygen Analyzer. By utilizing a check valve in the Tee Adapter, an airtight seal is maintained in-line,…
The MT 100 Oxygen Sensor Activation System is designed for use with the Maxtec Handi Oxygen Analyzer. By utilizing a check valve in the Tee Adapter, an airtight seal is maintained in-line, unless actuated by the stem of the activator. This system therefore provides the capability of rapid monitoring of the patient breathing environment without the inconvenience of breaking the ventilation circuit.
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for MT100 Oxygen Sensor Activation System | Listed by | Instrumentation Industries, Incorporated, United States |
| FDA product code | CCL |
| Device type | Analyzer, Gas, Oxygen, Gaseous-Phase |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-24 |
| Record revised | 2018-03-29 (version 2) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2016-09-30 |
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.