Catalog Number

-

Brand Name

VersaPAP™ Positive Airway Pressure Device

Version/Model Number

121501

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"

Yes

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

K173918,K173918,K173918,K173918

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

3c341a24-2a09-43a9-ac90-9d2ca5be9bc4

Public Version Date

February 27, 2020

Public Version Number

1

DI Record Publish Date

February 19, 2020

Package DI Number

10762860215013

Quantity per Package

10

Contains DI Package

00762860215016

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-