Catalog Number

-

Brand Name

Embrace TALK Blood Glucose Monitor (Pre-Pack)

Version/Model Number

APX03AB0300PRE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K090043

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

094a5e62-ce88-4e84-9eb5-49728213c3f1

Public Version Date

December 10, 2019

Public Version Number

1

DI Record Publish Date

December 02, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-