Catalog Number

-

Brand Name

VersaPAP® Positive Airway Pressure Device

Version/Model Number

121505

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

Product Code

BWF

Product Code Name

Spirometer, Therapeutic (Incentive)

Public Device Record Key

682398ee-b94a-4ff0-b58a-273ce887d8c7

Public Version Date

November 13, 2019

Public Version Number

1

DI Record Publish Date

November 05, 2019

Package DI Number

20762860215058

Quantity per Package

100

Contains DI Package

00762860215054

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-