Catalog Number

REA4081-43

Brand Name

TRUE METRIX AIR

Version/Model Number

TRUE METRIX AIR SELF MONITORING BLOOD GLUCOSE SYSTEM

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

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

44f444d8-daeb-4bd4-9c38-b7ce9bbd34ed

Public Version Date

November 12, 2018

Public Version Number

3

DI Record Publish Date

September 20, 2016

Package DI Number

10021292007581

Quantity per Package

12

Contains DI Package

00021292007584

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case