NA - CBCII Blood Conservation Kit with Round PVC Drain - STRYKER CORPORATION

Duns Number:196548481

Device Description: CBCII Blood Conservation Kit with Round PVC Drain and Curved Trocar

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More Product Details

Catalog Number

0225-028-514

Brand Name

NA

Version/Model Number

0225028514

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 01, 2019

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"

-

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

-

Product Code Details

Product Code

CAC

Product Code Name

APPARATUS, AUTOTRANSFUSION

Device Record Status

Public Device Record Key

06989901-c92b-47ab-97bc-c28ab70ca111

Public Version Date

February 19, 2020

Public Version Number

4

DI Record Publish Date

September 23, 2015

Additional Identifiers

Package DI Number

34546540867248

Quantity per Package

6

Contains DI Package

04546540867247

Package Discontinue Date

April 01, 2019

Package Status

Not in Commercial Distribution

Package Type

pack

"STRYKER CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2188
2 A medical device with a moderate to high risk that requires special controls. 3183
U Unclassified 60