B.BRAUN - HELP HEPARIN ADSORBER 400 US/CA - B.Braun Avitum AG

Duns Number:343689704

Device Description: HELP HEPARIN ADSORBER 400 US/CA

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

7211089

Brand Name

B.BRAUN

Version/Model Number

7211089

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

Product Code Details

Product Code

MMY

Product Code Name

LIPOPROTEIN, LOW DENSITY, REMOVAL

Device Record Status

Public Device Record Key

9889eaa1-57a6-4160-ad72-6d48b2e810fa

Public Version Date

April 29, 2019

Public Version Number

4

DI Record Publish Date

January 18, 2017

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