Catalog Number

XX*CXH25F

Brand Name

CAPIOX

Version/Model Number

XX*CXH25F

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

KRI

Product Code Name

ACCESSORY EQUIPMENT, CARDIOPULMONARY BYPASS

Public Device Record Key

34434fac-9bd3-4fe3-a53f-d66cf063bed7

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

54987350703762

Quantity per Package

4

Contains DI Package

04987350703767

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-