Duns Number:006811886
Device Description: EVA TPN BAG FOR PARENTERAL NUTRITION 1000ML
Catalog Number
-
Brand Name
Right Way Medical
Version/Model Number
RTPN1000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
November 19, 2020
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)
-
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
863c6438-454a-44a0-b002-3a1e07c8a869
Public Version Date
November 20, 2020
Public Version Number
2
DI Record Publish Date
April 01, 2019
Package DI Number
10860001018803
Quantity per Package
125
Contains DI Package
00860001018806
Package Discontinue Date
June 01, 2020
Package Status
Not in Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1 |