Catalog Number

-

Brand Name

M915-PCD, PCD Spirometer Kit

Version/Model Number

M9488-PCD

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

-

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

077ba55d-9bc3-41a4-8371-fd87b7ff870d

Public Version Date

March 08, 2022

Public Version Number

4

DI Record Publish Date

November 29, 2019

Package DI Number

06420099001087

Quantity per Package

1

Contains DI Package

06420099001094

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-