Catalog Number

67000

Brand Name

DYNEX Agility

Version/Model Number

67000

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JJQ

Product Code Name

Colorimeter, Photometer, Spectrophotometer For Clinical Use

Public Device Record Key

c2b5c387-a724-4cd2-aeaa-83146695c9e8

Public Version Date

September 16, 2022

Public Version Number

2

DI Record Publish Date

February 07, 2022

Package DI Number

15060456180055

Quantity per Package

1

Contains DI Package

05060456180058

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton