Catalog Number

-

Brand Name

Disposable Patient Interface with filter

Version/Model Number

0004-4012

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K150888

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Public Device Record Key

cadd86d7-3ffe-4cb8-a14b-84a86a723567

Public Version Date

March 07, 2022

Public Version Number

2

DI Record Publish Date

May 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-