Catalog Number

-

Brand Name

Spiro Handle

Version/Model Number

Spiro Handle

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K130322,K130322

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

a0732f86-9aaa-46fc-a293-ced6827a76f4

Public Version Date

March 08, 2022

Public Version Number

2

DI Record Publish Date

July 15, 2021

Package DI Number

18809276943726

Quantity per Package

4

Contains DI Package

08809276943729

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box