Catalog Number

-

Brand Name

LipidPlus® Meter

Version/Model Number

MD550

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

K130295

Product Code

CGA

Product Code Name

Glucose Oxidase, Glucose

Public Device Record Key

9162d105-0f41-4cbc-a103-a37397979360

Public Version Date

November 27, 2019

Public Version Number

4

DI Record Publish Date

February 16, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-