Duns Number:251731105
Device Description: Disposable thermistor intended for use during sleep disorders studies as a qualitative mea Disposable thermistor intended for use during sleep disorders studies as a qualitative measure of respiratory airflow for recording onto a data acquisition system.
Catalog Number
0517
Brand Name
BRAEBON Disposable Airflow Sensor
Version/Model Number
0517
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
Yes
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
K981445,K981445
Product Code
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
9c010991-34d8-43a5-abc3-e9b211794612
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 22, 2016
Package DI Number
B1400517241
Quantity per Package
24
Contains DI Package
B14005170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Bag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |