Duns Number:005146311
Device Description: Non-DEHP MICRO-VOLUME Extension Set, 0.2 Micron Downstream Filter, Male Luer Lock Adapter
Catalog Number
2N3350
Brand Name
NA
Version/Model Number
2N3350
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
K113227,K113227
Product Code
FPB
Product Code Name
Filter, infusion line
Public Device Record Key
e82cef31-4861-483a-ae92-5ba79de354c3
Public Version Date
October 19, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
50085412004841
Quantity per Package
50
Contains DI Package
00085412004846
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 |