Catalog Number

-

Brand Name

CareSens N POP

Version/Model Number

164422

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K120351,K120351

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

e7c285d5-99bf-4a1b-a87b-fae071776cf6

Public Version Date

November 18, 2020

Public Version Number

1

DI Record Publish Date

November 10, 2020

Package DI Number

10885325000433

Quantity per Package

70

Contains DI Package

00885325000436

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Case Carton