Duns Number:001292192
Device Description: SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB
Catalog Number
305780
Brand Name
BD Luer-Lok, BD Eclipse
Version/Model Number
305780
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
K010188,K010188,K010188
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
2e786103-d236-4c96-a213-764fafdca203
Public Version Date
September 12, 2018
Public Version Number
4
DI Record Publish Date
September 16, 2016
Package DI Number
50382903057806
Quantity per Package
6
Contains DI Package
30382903057802
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 |