Catalog Number

-

Brand Name

PEP

Version/Model Number

044B4612

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

-

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

a86206ca-c591-4d08-97fe-5e61998fe217

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 30, 2016

Package DI Number

00744229100423

Quantity per Package

12

Contains DI Package

00744229440383

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton