Catalog Number

2087075-300

Brand Name

CARESCAPE ONE

Version/Model Number

MBZ323

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K213234

Product Code

BZQ

Product Code Name

Monitor, breathing frequency

Public Device Record Key

ffba618d-4b4c-4f9d-8c65-be7f54bf9507

Public Version Date

May 25, 2022

Public Version Number

2

DI Record Publish Date

May 13, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-