Duns Number:053146767
Device Description: The BE 148-4 Cuff Pressure Monitor Adapter attaches to NS Series gauges with a 1/4" NPT fi The BE 148-4 Cuff Pressure Monitor Adapter attaches to NS Series gauges with a 1/4" NPT fitting to create a Cuff Pressure Monitor. During ventilation, the NS Series Cuff Pressure Monitors are devices used to periodically monitor endotracheal or tracheostomy tube balloon pressure to assure an adequate seal between the tube and the tracheal wall.These devices are intended to be used by or on the order of a physician.
Catalog Number
BE 148-4
Brand Name
Cuff Pressure Monitor Adapter
Version/Model Number
BE 148-4
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"
Yes
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
K081778
Product Code
CAP
Product Code Name
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
Public Device Record Key
df25a320-ce18-43cb-ba56-40ce7ebc30b9
Public Version Date
July 06, 2018
Public Version Number
4
DI Record Publish Date
May 31, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |