ALL-IN-ONE - ALL-IN-ONE Container, Empty EVA Container with - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: ALL-IN-ONE Container, Empty EVA Container with Three Lead Transfer Set, 2000 mL Capacity

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More Product Details

Catalog Number

2B8124

Brand Name

ALL-IN-ONE

Version/Model Number

2B8124

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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"

Yes

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

K090096,K090096

Product Code Details

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Device Record Status

Public Device Record Key

c5c0b544-a78a-4c7e-a732-79a6c461c0f6

Public Version Date

December 31, 2021

Public Version Number

7

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412042126

Quantity per Package

15

Contains DI Package

00085412042121

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358