Duns Number:053146767
Device Description: BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits components BE 127 Wye Connector with (2) 22mm OD ports and (1) 15mm ID/22mm OD port. Fits components of adult ventilator circuits. Reusable.
Catalog Number
BE 127
Brand Name
BE 127 Wye Connector
Version/Model Number
BE 127
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CAI
Product Code Name
Circuit, Breathing (W Connector, Adaptor, Y Piece)
Public Device Record Key
4992617c-1358-48ed-b3ab-061242bce12a
Public Version Date
May 20, 2019
Public Version Number
1
DI Record Publish Date
May 11, 2019
Package DI Number
M996BE1272
Quantity per Package
10
Contains DI Package
M996BE1270
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 |