ICU Medical - ICU MEDICAL, INC.

Duns Number:118380146

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More Product Details

Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

SF2075

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K964435,K964435

Product Code Details

Product Code

FMG

Product Code Name

Stopcock, i.V. Set

Device Record Status

Public Device Record Key

0b4d9c88-15da-4794-9a55-2746d94ce856

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

July 13, 2017

Additional Identifiers

Package DI Number

10840619046184

Quantity per Package

50

Contains DI Package

00840619046187

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ICU MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4887