Catalog Number

-

Brand Name

Dialysate Sack (SAK) with Concentrate

Version/Model Number

SAK-303

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

b76933bd-15b4-4e99-a3b2-b2f33a2ba76e

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2015

Package DI Number

M535SAK3035

Quantity per Package

2

Contains DI Package

M535SAK3030

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-