Catalog Number

12150194100

Brand Name

VersaPAP™ Positive Airway Pressure Device

Version/Model Number

121501

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 22, 2020

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

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

516f5ad8-5beb-4199-a46c-79cb8c340c08

Public Version Date

April 23, 2020

Public Version Number

3

DI Record Publish Date

March 27, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-