Duns Number:785952607
Device Description: 22MM SMOOTHBORE TUBE WITH SOFT END CONNECTORS, 22F-22F. 1.8M
Catalog Number
-
Brand Name
22MM SMOOTHBORE TUBE WITH SOFT END CONNECTORS, 22F-22F. 1.8M
Version/Model Number
5018000
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
1bef56be-1405-4592-a757-e47146645f9d
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
October 15, 2021
Package DI Number
05030267028597
Quantity per Package
20
Contains DI Package
05030267068944
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 |