Catalog Number

DP250-4

Brand Name

FloSense

Version/Model Number

Bidirectional

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 23, 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

69cacd7b-1877-494c-8066-70b494da2e80

Public Version Date

August 26, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-