Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

SF4053-S

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K080077,K080077

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Public Device Record Key

cccc11f7-f273-4a1b-b389-50b9e596289f

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

July 13, 2017

Package DI Number

10840619046214

Quantity per Package

50

Contains DI Package

00840619046217

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-