ICU Medical - 133" 15 Drop Primary Set w/BCV-Clave®, 4 Clave®, - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 133" 15 Drop Primary Set w/BCV-Clave®, 4 Clave®, Remv 4-Way Stopcock w/MicroClave®, Rotati 133" 15 Drop Primary Set w/BCV-Clave®, 4 Clave®, Remv 4-Way Stopcock w/MicroClave®, Rotating Luer, 1 Ext, Drop-In Ext Set w/MicroClave®

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More Product Details

Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

Z3900

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

8bce2159-b869-49d2-81e0-d1c6446b7a2e

Public Version Date

April 07, 2021

Public Version Number

7

DI Record Publish Date

November 07, 2017

Additional Identifiers

Package DI Number

10840619076600

Quantity per Package

25

Contains DI Package

00840619076603

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