Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

Z7102

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

9c1ed718-7fe5-4329-b0b7-afd19636363d

Public Version Date

July 23, 2020

Public Version Number

7

DI Record Publish Date

November 07, 2017

Package DI Number

10887709035826

Quantity per Package

25

Contains DI Package

00887709035829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-