Catalog Number

800704-904

Brand Name

MGC Diagnostics

Version/Model Number

762042-904

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K871711

Product Code

BZM

Product Code Name

Calculator, Pulmonary Function Interpretor (Diagnostic)

Public Device Record Key

c7e60e47-d3b5-4107-9ced-b336af1805b2

Public Version Date

March 08, 2022

Public Version Number

3

DI Record Publish Date

February 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-