ICU Medical - 139" (353 cm) 10 Drop Admin Set w/3 Clave? Clear, - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 139" (353 cm) 10 Drop Admin Set w/3 Clave? Clear, Check Valve, Remv 3-Gang NanoClave? Stop 139" (353 cm) 10 Drop Admin Set w/3 Clave? Clear, Check Valve, Remv 3-Gang NanoClave? Stopcocks w/Baseplate, Spin Luer, 2 Ext

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More Product Details

Catalog Number

AC238

Brand Name

ICU Medical

Version/Model Number

AC238

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

0bd99844-38a5-43f5-b78d-8b94bd5122bd

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Additional Identifiers

Package DI Number

10887709122458

Quantity per Package

25

Contains DI Package

00887709122451

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