APEX™ - EVA Single-Chamber Final Containers 2000 mL - B. BRAUN MEDICAL INC.

Duns Number:002397347

Device Description: EVA Single-Chamber Final Containers 2000 mL

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More Product Details

Catalog Number

2112531

Brand Name

APEX™

Version/Model Number

2112531

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

-

Product Code Details

Product Code

KPE

Product Code Name

CONTAINER, I.V.

Device Record Status

Public Device Record Key

5e3af595-1438-462f-8cc5-320b58336ffe

Public Version Date

March 27, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

04046964539213

Quantity per Package

8

Contains DI Package

04046964539206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"B. BRAUN MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 277
U Unclassified 2