Catalog Number

-

Brand Name

Shape-HF

Version/Model Number

Disposable Patient Interface

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K090722

Product Code

BTY

Product Code Name

Calculator, Predicted Values, Pulmonary Function

Public Device Record Key

f8b0507e-13e7-420e-9a79-6b80b90f962d

Public Version Date

March 07, 2022

Public Version Number

4

DI Record Publish Date

September 13, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-