Catalog Number

V-859215

Brand Name

Vyaire

Version/Model Number

V-859215

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K150810

Product Code

BZC

Product Code Name

Calculator, Pulmonary Function Data

Public Device Record Key

35fc5b48-d110-451f-aa8d-c11ddb5335b4

Public Version Date

March 16, 2021

Public Version Number

2

DI Record Publish Date

March 19, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-