Catalog Number

CSS-352

Brand Name

Peritoneal Dialysis

Version/Model Number

00884450462775

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FKX

Product Code Name

System, peritoneal, automatic delivery

Public Device Record Key

709cb2c0-8546-4a69-9f8e-cda5d11b0a3f

Public Version Date

November 10, 2021

Public Version Number

2

DI Record Publish Date

October 22, 2021

Package DI Number

10884450462772

Quantity per Package

1

Contains DI Package

00884450462775

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-