B.BRAUN - EMPTY BAGS FOR DIALYSATE FUTURA (US) - B.Braun Avitum AG

Duns Number:343689704

Device Description: EMPTY BAGS FOR DIALYSATE FUTURA (US)

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More Product Details

Catalog Number

7210930

Brand Name

B.BRAUN

Version/Model Number

7210930

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"

-

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

P940016,P940016,P940016,P940016,P940016,P940016

Product Code Details

Product Code

MMY

Product Code Name

LIPOPROTEIN, LOW DENSITY, REMOVAL

Device Record Status

Public Device Record Key

f1bf4846-0173-40a7-8146-d134ff23a5d5

Public Version Date

April 29, 2019

Public Version Number

4

DI Record Publish Date

January 18, 2017

Additional Identifiers

Package DI Number

04046963711184

Quantity per Package

25

Contains DI Package

04046964249679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton

"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