Duns Number:020275145
Device Description: Adapter, Syringe to NDD Syringe Adapter 5030-2
Catalog Number
115614
Brand Name
Adapter, Syringe to NDD Syringe Adapter 5030-2
Version/Model Number
Adapter, Syringe to NDD Syringe Adapter 5030-2
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
5d2f85e1-6dc6-4939-8092-e9cb1d70d3ef
Public Version Date
July 04, 2022
Public Version Number
2
DI Record Publish Date
February 02, 2022
Package DI Number
00817081027242
Quantity per Package
1
Contains DI Package
00817081027235
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 |