Catalog Number

-

Brand Name

FloChec

Version/Model Number

91-0004

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2017

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K093192

Product Code

JOM

Product Code Name

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Public Device Record Key

5f00a867-fddd-44c2-9bfe-8dadf50f8f4e

Public Version Date

June 02, 2022

Public Version Number

4

DI Record Publish Date

August 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-