POLYFLUX REVACLEAR MAX - Revaclear-Revaclear Max are indicated for the - GAMBRO RENAL PRODUCTS, INC.

Duns Number:929768682

Device Description: Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure Revaclear-Revaclear Max are indicated for the treatment of chronic and acute renal failure by hemodialysis

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More Product Details

Catalog Number

110634

Brand Name

POLYFLUX REVACLEAR MAX

Version/Model Number

110634

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 01, 2020

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

4f1ca14a-b06c-4d10-9c7e-528e3af526e3

Public Version Date

September 25, 2020

Public Version Number

6

DI Record Publish Date

October 07, 2015

Additional Identifiers

Package DI Number

37332414101702

Quantity per Package

24

Contains DI Package

07332414101701

Package Discontinue Date

March 01, 2020

Package Status

Not in Commercial Distribution

Package Type

CASE

"GAMBRO RENAL PRODUCTS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4