Catalog Number

-

Brand Name

PEP-S

Version/Model Number

018F63

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

K090829,K090829

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

3f90d82a-3af2-4f0e-9316-31c4ddf4691e

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

September 30, 2016

Package DI Number

00744229100003

Quantity per Package

12

Contains DI Package

00744229180128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton