Catalog Number

-

Brand Name

Alpha

Version/Model Number

6000

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

K212938,K212938

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

f78715cf-b664-46d0-bf15-4432af93c395

Public Version Date

March 14, 2022

Public Version Number

1

DI Record Publish Date

March 04, 2022

Package DI Number

05099169690028

Quantity per Package

1

Contains DI Package

15099169690025

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-