Catalog Number

-

Brand Name

Renpho Blood Glucose Monitoring System

Version/Model Number

3K-01-1400A2

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

Yes

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

-

FDA Premarket Submission

K121433,K121433

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

e566f7c2-183f-43ff-8d36-7e6c0173102c

Public Version Date

October 29, 2020

Public Version Number

1

DI Record Publish Date

October 21, 2020

Package DI Number

04711200722901

Quantity per Package

40

Contains DI Package

04711200722888

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX