Catalog Number

REA4094-01RX

Brand Name

TRUE METRIX AIR

Version/Model Number

TRUE METRIX AIR Self Monitoring Blood Glucose Meter

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)

Yes

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LFR

Product Code Name

Glucose Dehydrogenase, Glucose

Public Device Record Key

0f1f0ee6-1be4-49b5-a06b-b0f36f0737e5

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 30, 2021

Package DI Number

10681131403211

Quantity per Package

12

Contains DI Package

00681131403214

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE