Catalog Number

-

Brand Name

Model 4000

Version/Model Number

4000

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

K073155,K073155,K073155

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

75b9c8de-1c42-44cd-b5be-2b11989ffefe

Public Version Date

March 19, 2021

Public Version Number

4

DI Record Publish Date

December 12, 2016

Package DI Number

05099169400320

Quantity per Package

1

Contains DI Package

15099169400327

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-