Duns Number:053146767
Device Description: The Instrumentation Industries, Inc. BE 148-1 Gauge Adapter changes 1/4" NPT connection to The Instrumentation Industries, Inc. BE 148-1 Gauge Adapter changes 1/4" NPT connection to 1/8" small bore tubing connection.The BE 148-1 is designed to work with III Vacuum/Pressure Gauges and NIF Meters.The adapter is made of polycarbonate.
Catalog Number
BE 148-1
Brand Name
BE 148-1 Gauge Adapter
Version/Model Number
BE 148-1
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
K081693
Product Code
BXR
Product Code Name
Meter, Airway Pressure (Inspiratory Force)
Public Device Record Key
01e370c7-eb70-42cd-9153-eddcfa5fe48c
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 29, 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 |