Duns Number:785952607
Device Description: SUPERSET ELBOW 22M/15F, 15M, LUER + CAP
Catalog Number
-
Brand Name
SUPERSET ELBOW 22M/15F, 15M, LUER + CAP
Version/Model Number
1993001
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
7d484c32-9aaf-4300-b102-dec69f415765
Public Version Date
February 07, 2022
Public Version Number
2
DI Record Publish Date
October 14, 2021
Package DI Number
05030267088904
Quantity per Package
400
Contains DI Package
05030267058037
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 |