Catalog Number

-

Brand Name

CARESCAPE B450

Version/Model Number

MBA313

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

K191249

Product Code

BZK

Product Code Name

Spirometer, monitoring (w/wo alarm)

Public Device Record Key

ea78578c-c2d6-492e-b582-a9196aa1dc50

Public Version Date

April 27, 2022

Public Version Number

4

DI Record Publish Date

March 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-