Catalog Number

42801-04

Brand Name

ICU Medical

Version/Model Number

42801-04

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

K052828,K052828

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

4a3fe64a-4171-47af-ad17-d7cc5db73e94

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709120669

Quantity per Package

20

Contains DI Package

00887709120662

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS