Catalog Number

-

Brand Name

Safe-Lock®

Version/Model Number

050-95018

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

K124024,K124024

Product Code

KDJ

Product Code Name

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Public Device Record Key

100f5fe3-bdef-47ea-b3bf-a756bed74208

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100818

Quantity per Package

30

Contains DI Package

00840861100811

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case