Duns Number:053146767
Device Description: The reusable BE 131 One-Way Valve is designed for use in any breathing circuit or ventilat The reusable BE 131 One-Way Valve is designed for use in any breathing circuit or ventilatory system where "back flow" must be avoided. It is designed to prevent the flow of gas back toward the source.The device includes a silicone rubber connector with 22mm I.D. Inlet.
Catalog Number
-
Brand Name
BE 131 One-Way Valve
Version/Model Number
BE 131
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
K970780,K970780
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
dc7fda70-1428-4d5c-8830-31232cd74df8
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
M996BE1312
Quantity per Package
10
Contains DI Package
M996BE1310
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
bag
| 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 |