EVA TPN Bags - TPN EVA Bag 2000ml with Female big bore connector - VALMED SRL

Duns Number:434303011

Device Description: TPN EVA Bag 2000ml with Female big bore connector - DEHP free

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More Product Details

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

Product Characteristics

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 Details

Product Code

KPE

Product Code Name

Container, I.V.

Device Record Status

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

Additional Identifiers

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

-

"VALMED SRL" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 23