CLEARLINK - Y-Type Blood/Solution Set with Large Standard - BAXTER INTERNATIONAL INC.

Duns Number:005146311

Device Description: Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 170 to 260 M Y-Type Blood/Solution Set with Large Standard Blood Filter and Pressure Pump, 170 to 260 Micron Filter, 2 Luer Activated Valves, Male Luer Lock Adapter with Retractable Collar

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More Product Details

Catalog Number

4C8723

Brand Name

CLEARLINK

Version/Model Number

4C8723

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

K993120,K993120

Product Code Details

Product Code

BRZ

Product Code Name

Set, blood transfusion

Device Record Status

Public Device Record Key

f7920f57-52df-48ad-8bba-e76a491bfead

Public Version Date

November 19, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

50085412049071

Quantity per Package

48

Contains DI Package

00085412049076

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"BAXTER INTERNATIONAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 3
2 A medical device with a moderate to high risk that requires special controls. 358