Catalog Number

-

Brand Name

EVA TPN Bags

Version/Model Number

TPNEX3L

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

2648bdbd-d0e9-44d8-aadc-f5c5ac9593b3

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

March 08, 2019

Package DI Number

28033737862340

Quantity per Package

50

Contains DI Package

18033737862343

Package Discontinue Date

September 26, 2022

Package Status

Not in Commercial Distribution

Package Type

-