Catalog Number

V-378510

Brand Name

Vyntus

Version/Model Number

V-378510

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

-

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

K190853

Product Code

BZC

Product Code Name

CALCULATOR, PULMONARY FUNCTION DATA

Public Device Record Key

9580a36a-d6f5-4674-8cfe-22cac0e19ab6

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-