ICU Medical - ICU MEDICAL, INC.

Duns Number:118380146

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More Product Details

Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

SC125

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

K974589,K974589

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

9d9dec95-9611-4a1b-a14f-e7c169c47967

Public Version Date

April 07, 2021

Public Version Number

8

DI Record Publish Date

July 13, 2017

Additional Identifiers

Package DI Number

10887709040141

Quantity per Package

25

Contains DI Package

00887709040144

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