ICU Medical - 105" (267 cm) Y-Type 24 Hour Blood Set w/170 - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: 105" (267 cm) Y-Type 24 Hour Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Brav 105" (267 cm) Y-Type 24 Hour Blood Set w/170 Micron Filter, Hand Pump, Pre-Slit Port, Bravo24®, Rotating Luer, 1 Ext

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More Product Details

Catalog Number

-

Brand Name

ICU Medical

Version/Model Number

B9900-639

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

K983559,K983559

Product Code Details

Product Code

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Record Status

Public Device Record Key

22cb3727-46a0-40bc-996a-23caf709b103

Public Version Date

November 19, 2020

Public Version Number

5

DI Record Publish Date

April 23, 2017

Additional Identifiers

Package DI Number

10887709018102

Quantity per Package

25

Contains DI Package

00887709018105

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