Catalog Number

536713-004

Brand Name

MGC Diagnostics

Version/Model Number

536713-004

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

65926867-54bd-470c-ab91-8f1ea566f83d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 12, 2017

Package DI Number

536713004

Quantity per Package

100

Contains DI Package

B3685367130040

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton