Catalog Number

-

Brand Name

Dialysate Sack (SAK) with Concentrate

Version/Model Number

SAK-303-A

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

b3967348-be1c-49c7-8700-f8dbf1f67c02

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 30, 2015

Package DI Number

M535SAK303A5

Quantity per Package

2

Contains DI Package

M535SAK303A0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-