CAPIOX®FX - FX15 - TERUMO CORPORATION

Duns Number:690543319

Device Description: FX15

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More Product Details

Catalog Number

-

Brand Name

CAPIOX®FX

Version/Model Number

CX*FX15E

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

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

DTZ

Product Code Name

Oxygenator, Cardiopulmonary Bypass

Device Record Status

Public Device Record Key

49a14747-dc43-4564-85c2-af0e4fe368a9

Public Version Date

January 22, 2020

Public Version Number

3

DI Record Publish Date

September 15, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TERUMO CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 11
2 A medical device with a moderate to high risk that requires special controls. 364
3 A medical device with high risk that requires premarket approval 29