Catalog Number

-

Brand Name

CLEARUM HS

Version/Model Number

IBP4372

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

K193542,K193542

Product Code

KDI

Product Code Name

Dialyzer, high permeability with or without sealed dialysate system

Public Device Record Key

9dad7570-44c4-466c-beb9-3b60a351ca6b

Public Version Date

January 11, 2021

Public Version Number

1

DI Record Publish Date

January 01, 2021

Package DI Number

68051736004156

Quantity per Package

21

Contains DI Package

08051736004154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE