Catalog Number

-

Brand Name

SPIRO-BALL

Version/Model Number

L25913000

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

K053149,K053149

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

9176dfec-b966-41b2-a012-02d3d0447879

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 12, 2017

Package DI Number

18436020761840

Quantity per Package

12

Contains DI Package

08436020761843

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box