Catalog Number

-

Brand Name

Pneumotach

Version/Model Number

Pneumotach, white and grey

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K080734,K082539,K202754

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Public Device Record Key

2e05f0b8-e31a-4c7b-b9f9-b9ed84df16ba

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

July 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-