Catalog Number

46105-56

Brand Name

ICU Medical

Version/Model Number

46105-56

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

K061573,K061573

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Public Device Record Key

3a746f83-cb44-4e2a-9a6a-33bd147b6232

Public Version Date

October 27, 2021

Public Version Number

1

DI Record Publish Date

October 19, 2021

Package DI Number

10840619068841

Quantity per Package

25

Contains DI Package

00840619068844

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS