Catalog Number

011-A1000

Brand Name

ICU Medical

Version/Model Number

011-A1000

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K970855,K970855

Product Code

FPA

Product Code Name

Set, administration, intravascular

Public Device Record Key

dcaad441-3eb8-4a1c-8eff-66e898f5bcb0

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

10840619060906

Quantity per Package

100

Contains DI Package

00840619060909

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BX