Duns Number:434303011
Device Description: TPN EVA Bag 2000ml with Female big bore connector - DEHP free
Catalog Number
-
Brand Name
EVA TPN Bags
Version/Model Number
FVM0037BP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 21, 2022
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
-
Product Code
KPE
Product Code Name
Container, I.V.
Public Device Record Key
c5a902dc-ff5b-416a-a341-189066e864c0
Public Version Date
April 22, 2022
Public Version Number
3
DI Record Publish Date
December 05, 2018
Package DI Number
28033737862302
Quantity per Package
50
Contains DI Package
18033737862305
Package Discontinue Date
April 21, 2022
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |