Duns Number:251731105
Device Description: Belt intended for use during sleep disorder studies as a measure of respiratory effort for Belt intended for use during sleep disorder studies as a measure of respiratory effort for recording with a MediByte.
Catalog Number
8574
Brand Name
BRAEBON RIP Belt for MediByte, Large
Version/Model Number
8574
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
K001743
Product Code
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
e52a6be2-baed-4a56-bc58-50bf98262a8e
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 |