Catalog Number

51021

Brand Name

Patient Safe®

Version/Model Number

51021

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

K101708,K101708,K101708

Product Code

FMF

Product Code Name

Syringe, Piston

Public Device Record Key

9166dde5-5f40-445a-bb42-4e18b41bd006

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 22, 2016

Package DI Number

00613703510228

Quantity per Package

160

Contains DI Package

00613703510204

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case