Duns Number:785952607
Device Description: 22MM SMOOTHBORE BILEVEL BREATHING SYSTEM WITH SWIVEL CO2 LEAK PORT AND FILTER. 1.8M
Catalog Number
-
Brand Name
22MM SMOOTHBORE BILEVEL BS WITH SWIVEL CO2 LEAK PORT AND FILTER. 1.8M
Version/Model Number
5805030
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
9a4431a9-5def-4aa9-9048-c9b6f1d698ff
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
October 15, 2021
Package DI Number
05030267156047
Quantity per Package
30
Contains DI Package
05030267156030
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 222 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |