Duns Number:053146767
Device Description: Specialty Adapter with Vent - 15mm ID/22mm OD/15mm ID/22mm OD. Fits components of adult ve Specialty Adapter with Vent - 15mm ID/22mm OD/15mm ID/22mm OD. Fits components of adult ventilator circuits. Molded of polycarbonate. Reusable.
Catalog Number
BE 106
Brand Name
BE 106 Adult Adapter with Vent
Version/Model Number
BE 106
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
fbc1c098-9100-42de-b64d-d7735e6fab58
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
July 21, 2017
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 |