Catalog Number

-

Brand Name

LC

Version/Model Number

041F3500

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K972042,K972042

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

f56e64a1-5d32-4af5-9c9c-5146372c724f

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

November 17, 2016

Package DI Number

00744229100355

Quantity per Package

12

Contains DI Package

00744229410881

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton