Catalog Number

-

Brand Name

AgaMatrix

Version/Model Number

8000-04034

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

-

Product Code

NBW

Product Code Name

System, Test, Blood Glucose, Over The Counter

Public Device Record Key

0113a383-5251-415a-adc8-30efad6e2bc1

Public Version Date

December 03, 2018

Public Version Number

4

DI Record Publish Date

November 04, 2016

Package DI Number

30385544036014

Quantity per Package

20

Contains DI Package

20385544036017

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Shipper