Catalog Number

29-8021

Brand Name

FloSense

Version/Model Number

BiDirectional

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 31, 2019

Issuing Agency

In HIBCC

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K990962,K990962

Product Code

JAX

Product Code Name

Pneumotachometer

Public Device Record Key

9dda8d16-2a97-43bd-b7f5-bd542939b9bd

Public Version Date

August 26, 2019

Public Version Number

4

DI Record Publish Date

July 26, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-