ICU Medical - Primary PLUM Set, CLAVE Secondary Port, 0.2 - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Primary PLUM Set, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene-Line Primary PLUM Set, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene-Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch

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More Product Details

Catalog Number

15256-28

Brand Name

ICU Medical

Version/Model Number

15256-28

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

K141789,K141789

Product Code Details

Product Code

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

9ac6d8ea-a1de-4395-872b-f4bf5a009766

Public Version Date

November 26, 2021

Public Version Number

1

DI Record Publish Date

November 18, 2021

Additional Identifiers

Package DI Number

10887709102351

Quantity per Package

50

Contains DI Package

00887709102354

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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