Duns Number:053146767
Device Description: The reusable BE 117 Non-Rebreathing ‘T’ is designed for use with a spontaneously breathing The reusable BE 117 Non-Rebreathing ‘T’ is designed for use with a spontaneously breathing patient where “back flow” must be avoided. The ‘T’ is designed to prevent the flow of gas back toward the source and to ensure unilateral breathing.
Catalog Number
-
Brand Name
BE 117 Non-Rebreathing Tee Valve
Version/Model Number
BE 117
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
K973066,K973066
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
30aa1d2c-37b1-4610-b64e-4bdf30a87390
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
M996BE1172
Quantity per Package
10
Contains DI Package
M996BE1170
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
ziplock 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 |