CDI™ Blood Parameter Monitoring System 550 - Monitor Pole Clamp, 4.5" Short, Calibrator Mount, - Terumo Cardiovascular Systems Corporation

Duns Number:177655466

Device Description: Monitor Pole Clamp, 4.5" Short, Calibrator Mount, for use with the CDI System 550 Monitor

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More Product Details

Catalog Number

CDI518

Brand Name

CDI™ Blood Parameter Monitoring System 550

Version/Model Number

CDI518

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"

-

For Single-Use

-

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

KRI

Product Code Name

Accessory Equipment, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

5088c204-619e-4fb3-a431-51ccb0eb20de

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TERUMO CARDIOVASCULAR SYSTEMS CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 36
2 A medical device with a moderate to high risk that requires special controls. 174