Catalog Number

1004-01

Brand Name

Lung Flute® for Hospitals & Clinics

Version/Model Number

1004-01

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K091557,K060439,K060439,K091557,K091557,K060439

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

fecb2e07-4dd5-4a71-97b5-8ed02b0dd0f9

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

January 31, 2017

Package DI Number

20816133010007

Quantity per Package

5

Contains DI Package

10816133010000

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case