Catalog Number

-

Brand Name

O-PEP

Version/Model Number

018F65

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

K150044,K150044

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

3341bcd8-bc70-4204-b7ba-a48ccbbd0979

Public Version Date

June 22, 2021

Public Version Number

4

DI Record Publish Date

June 30, 2017

Package DI Number

00744229100010

Quantity per Package

6

Contains DI Package

00744229180142

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton