Catalog Number

-

Brand Name

Spirotrac

Version/Model Number

7000

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

K141546,K141546,K141546

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

117de4c7-117a-4d05-b806-3427bf8e3f90

Public Version Date

March 08, 2022

Public Version Number

5

DI Record Publish Date

December 14, 2016

Package DI Number

05099169706101

Quantity per Package

1

Contains DI Package

15099169676807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-