Catalog Number

SA-1255

Brand Name

Peritoneal Dialysis Catheter

Version/Model Number

SA-1255

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K993149

Product Code

FJS

Product Code Name

Catheter, Peritoneal, Long-Term Indwelling

Public Device Record Key

a64a3185-760e-49ab-a98c-5d5b31d3d09e

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

April 09, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-