Catalog Number

AG8075

Brand Name

ICU Medical

Version/Model Number

AG8075

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

K932141,K932141

Product Code

DQO

Product Code Name

Catheter, intravascular, diagnostic

Public Device Record Key

cdb42b7d-080a-4e6d-8346-9abb4d6025f6

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

10887709053707

Quantity per Package

25

Contains DI Package

00887709053700

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS