Duns Number:053146767
Device Description: General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Mold General Adapter - 22mm ID x 22mm ID adapter for use in breathing/ventilator circuit. Molded of polystyrene butadiene, Single Patient Use.
Catalog Number
BE 105-2X22D
Brand Name
BE 105-2X22D Adapter
Version/Model Number
BE 105-2X22D
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
Yes
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
ebf5640d-0138-4b5c-9ac3-626fbfe92b3c
Public Version Date
October 21, 2020
Public Version Number
5
DI Record Publish Date
July 21, 2017
Package DI Number
M996BE1052X22D3
Quantity per Package
20
Contains DI Package
M996BE1052X22D0
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 |