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.
Catalog Number
0585
Brand Name
Ultima Dual Pressure Sensor.
Version/Model Number
0585
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
5356f466-795c-47fb-8e16-acc2042efc62
Public Version Date
November 15, 2019
Public Version Number
1
DI Record Publish Date
November 07, 2019
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 |