Duns Number:434303011
Device Description: TPN EVA BAG COMP 3000 ML DEHP FREE 1LG WOLF-PACK
Catalog Number
-
Brand Name
EVA TPN Bags
Version/Model Number
TPNCP3L
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 26, 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
b9e4b788-ccaa-4cd8-8ae2-8d5aa4c1443c
Public Version Date
September 27, 2022
Public Version Number
4
DI Record Publish Date
September 20, 2016
Package DI Number
28033737862241
Quantity per Package
50
Contains DI Package
18033737862244
Package Discontinue Date
September 26, 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 |