EVA TPN Bags - TPN BAG GRAV 500ML 3LG - VALMED SRL

Duns Number:434303011

Device Description: TPN BAG GRAV 500ML 3LG

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More Product Details

Catalog Number

-

Brand Name

EVA TPN Bags

Version/Model Number

TPNGR500ML

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 26, 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

428a142a-3adc-493a-ab6d-50bf1262064e

Public Version Date

September 27, 2022

Public Version Number

3

DI Record Publish Date

March 08, 2019

Additional Identifiers

Package DI Number

28033737862364

Quantity per Package

50

Contains DI Package

18033737862367

Package Discontinue Date

September 26, 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