Duns Number:251731105
Device Description: The MediByte is a portable sleep data recorder used to record physiological signals during The MediByte 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. Kit contains: 1 MediByte; 2 Q-RIP Effort Belts; 6 MediByte Electrode Prep Kits; 6 Self-Adhesive Electrodes; 1 Snore Microphone with Thermistor Input; I Electrode Box; 24" and 60" Leadwire Kit; 1 cTherm Cannula Thermistor; 1 SpO2 sensor; 1 Communication Cable;
Catalog Number
MP8KN
Brand Name
BRAEBON MediByte
Version/Model Number
MP8KN
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K061764
Product Code
MNR
Product Code Name
Ventilatory Effort Recorder
Public Device Record Key
2ed5350c-6b40-4bd2-832b-1af125b21e50
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |