Catalog Number

-

Brand Name

Cascade IOMAX

Version/Model Number

199291-200

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

K162199

Product Code

DQA

Product Code Name

Oximeter

Public Device Record Key

77fa1ed0-6d8b-4b75-8407-20c9bffe866e

Public Version Date

December 18, 2020

Public Version Number

1

DI Record Publish Date

December 10, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-