Catalog Number

ES-04218

Brand Name

ARROW

Version/Model Number

IPN033138

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K781978,K781978

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

409ef1ba-84dd-4ba4-92b8-2aab6a32b423

Public Version Date

February 19, 2021

Public Version Number

6

DI Record Publish Date

September 16, 2016

Package DI Number

30801902100543

Quantity per Package

10

Contains DI Package

00801902100542

Package Discontinue Date

October 18, 2019

Package Status

Not in Commercial Distribution

Package Type

Case