Duns Number:020275145
Device Description: Adapter, NDD Syringe Adapter 2030-3
Catalog Number
115617
Brand Name
Adapter, NDD Syringe Adapter 2030-3
Version/Model Number
NDD Syringe Adapter 2030-3, 115617
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"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
0c97b942-8756-46dc-b632-dbf95bc19f81
Public Version Date
October 19, 2022
Public Version Number
1
DI Record Publish Date
October 11, 2022
Package DI Number
00817081027389
Quantity per Package
1
Contains DI Package
00817081027372
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. | 126 |