Diacap® - Diacap® Pro 16H - B.Braun Avitum AG

Duns Number:343689704

Device Description: Diacap® Pro 16H

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More Product Details

Catalog Number

720DH16

Brand Name

Diacap®

Version/Model Number

720DH16

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

-

Product Code Details

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Device Record Status

Public Device Record Key

b7ed6a64-8d28-41c2-a614-5c9535c1029e

Public Version Date

April 02, 2021

Public Version Number

6

DI Record Publish Date

October 12, 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