Catalog Number

150400

Brand Name

MAXII

Version/Model Number

MAXII

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K922660

Product Code

BZL

Product Code Name

Computer, Oxygen-Uptake

Public Device Record Key

4fda0fcd-2727-4ce6-8d7f-feb3ff29bed1

Public Version Date

November 11, 2021

Public Version Number

1

DI Record Publish Date

November 03, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-