Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

SC9033

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

0447ead7-8e7e-4dd1-9dfc-a981ec039922

Public Version Date

October 23, 2019

Public Version Number

2

DI Record Publish Date

July 08, 2019

Package DI Number

10887709040509

Quantity per Package

100

Contains DI Package

00887709040502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-