Catalog Number

BX02

Brand Name

ICU Medical

Version/Model Number

BX02

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

K913804,K913804

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

a8e80c60-5ade-4b06-903a-625df7e379dc

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709080598

Quantity per Package

25

Contains DI Package

00887709080591

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS