Duns Number:001292192
Device Description: SYRINGE 1ML LL
Catalog Number
309628
Brand Name
BD Luer-Lok
Version/Model Number
309628
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
Yes
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
K941562,K941562,K941562
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
3d3ade62-2e0e-4f7a-883e-e86e74d3dcea
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382903096287
Quantity per Package
8
Contains DI Package
30382903096283
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 611 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 614 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 4 |