Catalog Number

852828

Brand Name

Vyntus

Version/Model Number

852828

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 29, 2020

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K122699

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

1e0b04ef-25ad-42e6-8a0a-dc7491ec4d3b

Public Version Date

March 16, 2021

Public Version Number

4

DI Record Publish Date

July 31, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-