Catalog Number

-

Brand Name

InSure® ONE™

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K170548,K170548,K170548

Product Code

KHE

Product Code Name

Reagent, Occult Blood

Public Device Record Key

e4961a21-93c7-4e98-82d2-c305ae2d5e68

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

January 05, 2018

Package DI Number

00850093003347

Quantity per Package

200

Contains DI Package

00850093003323

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Pouch