Right Way Medical - EVA TPN BAG FOR PARENTERAL NUTRITION 1000ML - RIGHT WAY MEDICAL LLC

Duns Number:006811886

Device Description: EVA TPN BAG FOR PARENTERAL NUTRITION 1000ML

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More Product Details

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

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)

-

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

863c6438-454a-44a0-b002-3a1e07c8a869

Public Version Date

November 20, 2020

Public Version Number

2

DI Record Publish Date

April 01, 2019

Additional Identifiers

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

"RIGHT WAY MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 1