Catalog Number

-

Brand Name

Safe-Lock®

Version/Model Number

050-30026

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

K896764,K896764

Product Code

KDJ

Product Code Name

SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Public Device Record Key

e952affe-efc3-4b37-9fd9-b45a0a18f54a

Public Version Date

September 28, 2020

Public Version Number

3

DI Record Publish Date

October 02, 2015

Package DI Number

10840861100665

Quantity per Package

150

Contains DI Package

00840861100668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-