Duns Number:251731105
Device Description: Ultima Pressure Transducers are for use during sleep disorder studies as a measure of resp Ultima Pressure Transducers are for use during sleep disorder studies as a measure of respiratory airflow (hypopneas and apneas) and/ or esophageal pressure for recording onto a data acquisition system. Kit contains Ultima Pressure Sensor; Ultima Pressure Sensor Interface: Pure, Filter, Snoring; Interface Strap; 3 Micro Cannulae; 2 Oral + Nasal Cannulae.
Catalog Number
0580L
Brand Name
BRAEBON PT Lite Low Gain Pressure Transducer Kit
Version/Model Number
0580L
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
K984431
Product Code
BZQ
Product Code Name
Monitor, Breathing Frequency
Public Device Record Key
06345695-8db4-4431-a034-d894aca7be41
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 |