B.BRAUN - The Plasmat® Futura System - B.Braun Avitum AG

Duns Number:343689704

Device Description: The Plasmat® Futura System

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More Product Details

Catalog Number

706210A

Brand Name

B.BRAUN

Version/Model Number

706210A

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 29, 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

-

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

MMY

Product Code Name

LIPOPROTEIN, LOW DENSITY, REMOVAL

Device Record Status

Public Device Record Key

d0d27921-3b92-48c2-9d7b-6670fa88d503

Public Version Date

September 30, 2022

Public Version Number

6

DI Record Publish Date

September 15, 2014

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"B.BRAUN AVITUM AG" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 69
3 A medical device with high risk that requires premarket approval 1