Catalog Number

8-209503-00

Brand Name

Whisperflow CPAP Valve

Version/Model Number

00

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

Yes

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

K950397,K950397

Product Code

BYE

Product Code Name

Attachment, breathing, positive end expiratory pressure

Public Device Record Key

6e9a2154-e319-4806-b05e-6444cc8d733b

Public Version Date

June 24, 2021

Public Version Number

4

DI Record Publish Date

December 14, 2016

Package DI Number

30884838083289

Quantity per Package

10

Contains DI Package

00884838083288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multipack