Catalog Number

48160

Brand Name

MC3 Nautilus Oxygenator Holder

Version/Model Number

48160

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

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

a85d32c7-4242-48d4-8692-24fd60512ae9

Public Version Date

May 11, 2020

Public Version Number

1

DI Record Publish Date

May 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-