Catalog Number

N4010-2-VAC

Brand Name

Spirometrics

Version/Model Number

N4010

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 28, 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

-

Product Code

BXW

Product Code Name

Calibrator, Volume, Gas

Public Device Record Key

fd14edf4-7773-41dc-b609-e2c4b688cdce

Public Version Date

September 24, 2020

Public Version Number

3

DI Record Publish Date

April 03, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-