Catalog Number

52001

Brand Name

Patient Safe®

Version/Model Number

52001

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K072654,K072654,K072654

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

fc1039fe-95f3-4417-a5a7-7d1c8d0e13b5

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

00613703520029

Quantity per Package

4

Contains DI Package

00613703520012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case