Catalog Number

160379203

Brand Name

ICU Medical MedNet

Version/Model Number

6.32.0

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K141102

Product Code

PHC

Product Code Name

Infusion safety management software

Public Device Record Key

b82d644c-e98e-4568-821c-d3e9927ef955

Public Version Date

January 22, 2020

Public Version Number

2

DI Record Publish Date

October 09, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-