Catalog Number

DP201-1

Brand Name

FloSense

Version/Model Number

Klip

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,K990962

Product Code

JAX

Product Code Name

Pneumotachometer

Public Device Record Key

f2efd231-f602-43c2-a304-60d53b672d9b

Public Version Date

August 26, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

B279DP2010

Quantity per Package

50

Contains DI Package

B279DP2011

Package Discontinue Date

August 15, 2019

Package Status

Not in Commercial Distribution

Package Type

case