Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

NC100

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

-

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

388b3fe3-7453-4877-9b8d-6393c00cb664

Public Version Date

May 19, 2020

Public Version Number

6

DI Record Publish Date

July 13, 2017

Package DI Number

10840619065482

Quantity per Package

100

Contains DI Package

00840619065485

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-