Catalog Number

50301

Brand Name

Patient Safe®

Version/Model Number

50301

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

673b4a73-f58f-4053-8c99-60f0d26bdaca

Public Version Date

September 12, 2018

Public Version Number

4

DI Record Publish Date

September 22, 2016

Package DI Number

00613703503022

Quantity per Package

8

Contains DI Package

00613703503015

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case