Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CH3324

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

K080989,K080989

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

6416a5d1-8f03-44c9-a28c-f54b25f4c855

Public Version Date

March 10, 2021

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

10840619054240

Quantity per Package

50

Contains DI Package

00840619054243

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-