Catalog Number

12510-01

Brand Name

ICU Medical

Version/Model Number

12510-01

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

K090189,K090189

Product Code

LHI

Product Code Name

Set, i.V. Fluid transfer

Public Device Record Key

92dcacdd-c2f2-4814-b8bb-5c6dd7e26606

Public Version Date

September 01, 2021

Public Version Number

1

DI Record Publish Date

August 24, 2021

Package DI Number

10887709050522

Quantity per Package

100

Contains DI Package

00887709050525

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS