Catalog Number

-

Brand Name

Spiroguard

Version/Model Number

2800/21BAUC001/0001

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K051712,K051712,K051712

Product Code

BZG

Product Code Name

Spirometer, Diagnostic

Public Device Record Key

9bf8051f-fdbd-4a62-a75e-5ebf2db4faa5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

35060120951671

Quantity per Package

200

Contains DI Package

25060120951674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer box