Catalog Number

75050

Brand Name

Prodigy No Coding Blood Glucose Test Strips

Version/Model Number

75050

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K073118,K073118,K073118

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

d353cb4d-bf1c-4a9b-940d-f9c0462fd87b

Public Version Date

February 18, 2019

Public Version Number

1

DI Record Publish Date

January 16, 2019

Package DI Number

30384840750501

Quantity per Package

10

Contains DI Package

00384840750500

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Corrugated Box