Catalog Number

-

Brand Name

stay•safe® organizer holder

Version/Model Number

030-10808

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

K173718,K173718

Product Code

FKX

Product Code Name

System, Peritoneal, Automatic Delivery

Public Device Record Key

ed0e760c-e171-45df-99a6-825d048435b2

Public Version Date

October 21, 2019

Public Version Number

2

DI Record Publish Date

May 09, 2019

Package DI Number

10840861102300

Quantity per Package

40

Contains DI Package

00840861102303

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case