Catalog Number

-

Brand Name

PULMO-PROTECT LUNG FUNCTION FILTER

Version/Model Number

1691000

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

Yes

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

-

FDA Premarket Submission

K013123,K013123

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

6f35c5ef-55d3-49d4-9732-b793358f9de1

Public Version Date

July 25, 2022

Public Version Number

1

DI Record Publish Date

July 15, 2022

Package DI Number

05030267135738

Quantity per Package

50

Contains DI Package

05030267135721

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-