Duns Number:005146311
Device Description: Solution Set, Male Epidural Non-Luer Lock Adapter For Epidural Use
Catalog Number
2E7554
Brand Name
NA
Version/Model Number
2E7554
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"
Yes
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
K161323,K161323
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
8a2159c6-86b2-4342-9c14-a9f32a121428
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 17, 2017
Package DI Number
50085412563713
Quantity per Package
48
Contains DI Package
00085412563718
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 | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 358 |