Catalog Number

BX01

Brand Name

ICU Medical

Version/Model Number

BX01

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

ea8c2731-2b85-4ffc-9604-11dc85694a04

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Package DI Number

10887709080093

Quantity per Package

30

Contains DI Package

00887709080096

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS