The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty…
The MediByte Jr. is a portable sleep data recorder used to record physiological signals during sleep while the patient is either at home or in a clinical environment. This is a new warranty replacement unit.
Who Else Makes It
Concentrated in Fujian (1), Jiangsu (1), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Braebon MediByte Jr. | Listed by | Braebon Medical Corp., Canada |
| FDA product code | MNR |
| Device type | Ventilatory Effort Recorder |
| Device class | Class 2 |
| Regulation | 21 CFR 868.2375 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K061764 |
| Record published | 2016-09-22 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 95 % RH; Storage environment temperature 0 to 60 °C |
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.