Catalog Number

3-702

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

3-702

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Public Device Record Key

20f4d4c8-d4a2-4f63-b9ee-f72fcbc0ca19

Public Version Date

November 18, 2020

Public Version Number

4

DI Record Publish Date

February 15, 2018

Package DI Number

10852676007763

Quantity per Package

4

Contains DI Package

00852676007766

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-