ICU Medical - 141" (358 cm) 10 Drop Admin Set w/2 Check Valves, - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 141" (358 cm) 10 Drop Admin Set w/2 Check Valves, 4 Clave? Clear, Remv 3-Gang 4-Way Stopco 141" (358 cm) 10 Drop Admin Set w/2 Check Valves, 4 Clave? Clear, Remv 3-Gang 4-Way Stopcocks w/Baseplate, Spin Luer w/Filter Cap, 2 Ext

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More Product Details

Catalog Number

MC330690

Brand Name

ICU Medical

Version/Model Number

MC330690

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

c441b956-e66f-4942-a827-db2cc5754e6b

Public Version Date

September 03, 2021

Public Version Number

1

DI Record Publish Date

August 26, 2021

Additional Identifiers

Package DI Number

10887709124001

Quantity per Package

25

Contains DI Package

00887709124004

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