Catalog Number

-

Brand Name

In2itive

Version/Model Number

2120

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

Yes

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

-

FDA Premarket Submission

K100687

Product Code

BZG

Product Code Name

SPIROMETER, DIAGNOSTIC

Public Device Record Key

47e2e39b-ca7a-41cc-ba4c-f943842424b0

Public Version Date

March 08, 2022

Public Version Number

6

DI Record Publish Date

November 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-