Duns Number:434303011
Device Description: TPN EVA BAG GRAV 3000ML DEHP FREE 3LG WOLF-PACK
Catalog Number
-
Brand Name
EVA TPN Bags
Version/Model Number
WP-TPNGR3L
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
-
Product Code
KPE
Product Code Name
Container, I.V.
Public Device Record Key
6dbc6fc7-0e34-4329-b267-cc0cf8c6dd1f
Public Version Date
April 29, 2022
Public Version Number
1
DI Record Publish Date
April 21, 2022
Package DI Number
18056209141906
Quantity per Package
50
Contains DI Package
08056209141909
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 23 |