Catalog Number

-

Brand Name

stay.safe®

Version/Model Number

050-95003

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"

Yes

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

K173593,K822550,K173593,K822550

Product Code

KDJ

Product Code Name

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Public Device Record Key

6ad93d80-aa82-40a5-a65e-b1563b6e30a1

Public Version Date

March 30, 2020

Public Version Number

6

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100771

Quantity per Package

100

Contains DI Package

00840861100774

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-