Catalog Number

-

Brand Name

PHOENIX DIAGNOSTICS, INC.

Version/Model Number

PH7001

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

7b53ff84-4536-4d2e-8d35-a91645701e79

Public Version Date

December 21, 2020

Public Version Number

4

DI Record Publish Date

January 26, 2018

Package DI Number

10853366007452

Quantity per Package

10

Contains DI Package

00853366007455

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-