EVA TPN Bags - TPN EVA BAG COMP 1000 ML DEHP FREE 1LG WOLF-PACK - VALMED SRL

Duns Number:434303011

Device Description: TPN EVA BAG COMP 1000 ML DEHP FREE 1LG WOLF-PACK

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More Product Details

Catalog Number

-

Brand Name

EVA TPN Bags

Version/Model Number

TPNCP1L

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

58e592a0-516d-4f31-a948-a3e6e40e867f

Public Version Date

September 27, 2022

Public Version Number

4

DI Record Publish Date

September 20, 2016

Additional Identifiers

Package DI Number

28033737862227

Quantity per Package

50

Contains DI Package

18033737862220

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