Catalog Number

536719-001

Brand Name

MGC Diagnostics

Version/Model Number

536719-001

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"

Yes

For Single-Use

Yes

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

K042758,K042758

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

942c9ac5-8e24-4d24-8428-0a8f64bf4d9e

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

536719001

Quantity per Package

100

Contains DI Package

B3685367190010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton