Catalog Number

-

Brand Name

Streamline Express Dialyzer with Pre-attached Tubing Set For Fresenius 2008 Seri

Version/Model Number

SLE-3000M3095

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2021

Issuing Agency

In HIBCC

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"

Yes

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

KDI

Product Code Name

Dialyzer, High Permeability With Or Without Sealed Dialysate System

Public Device Record Key

b9578893-5ca7-4839-9b2f-cef9e9ecd76b

Public Version Date

November 18, 2021

Public Version Number

4

DI Record Publish Date

September 01, 2015

Package DI Number

M535SLE3000M30955

Quantity per Package

15

Contains DI Package

M535SLE3000M30950

Package Discontinue Date

July 31, 2021

Package Status

Not in Commercial Distribution

Package Type

-