Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

CL-78

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

K070633,K070633

Product Code

FMF

Product Code Name

Syringe, piston

Public Device Record Key

918a3e6c-bbaf-473f-87de-427eff0c8ea3

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

July 10, 2017

Package DI Number

10887709062457

Quantity per Package

50

Contains DI Package

00887709062450

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-