Catalog Number

15022

Brand Name

InSure FIT

Version/Model Number

01

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

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

K002457,K002457,K002457,K002457

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

8d4a50ac-3108-4ec4-8cf7-a5470052fa29

Public Version Date

April 08, 2022

Public Version Number

8

DI Record Publish Date

September 14, 2016

Package DI Number

10850093003061

Quantity per Package

10

Contains DI Package

00850093003064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton