ICU Medical - 8" Smallbore Trifuse Ext Set w/Remv MicroClave® - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 8" Smallbore Trifuse Ext Set w/Remv MicroClave® Clear, 0.2 Micron Filter, 4 Clamps, Rotati 8" Smallbore Trifuse Ext Set w/Remv MicroClave® Clear, 0.2 Micron Filter, 4 Clamps, Rotating Luer

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More Product Details

Catalog Number

MC33337

Brand Name

ICU Medical

Version/Model Number

MC33337

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)

Yes

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

1f2da197-ec5f-4431-8474-8e27136f14df

Public Version Date

October 26, 2021

Public Version Number

2

DI Record Publish Date

August 03, 2021

Additional Identifiers

Package DI Number

10887709037851

Quantity per Package

50

Contains DI Package

00887709037854

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"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