Catalog Number

-

Brand Name

MCG Diagnostics

Version/Model Number

536757-EW

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"

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

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

a74028e6-52fb-4abc-af4f-98f9eec127e3

Public Version Date

June 10, 2019

Public Version Number

1

DI Record Publish Date

June 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-