Catalog Number

-

Brand Name

Dialysate Sack (SAK) with Concentrate

Version/Model Number

SAK-401

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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"

-

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

FKR

Product Code Name

Subsystem, Proportioning

Public Device Record Key

9c8a3836-9d51-4c81-9d7d-c2d25bbd2444

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2015

Package DI Number

M535SAK4015

Quantity per Package

2

Contains DI Package

M535SAK4010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-