Catalog Number

-

Brand Name

Phoenix Diagnostics

Version/Model Number

3-221

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

K902267,K902267

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Public Device Record Key

b7f902d9-4a2f-4e53-aeca-2aca1cf0a7a5

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

August 12, 2017

Package DI Number

01085267600704

Quantity per Package

6

Contains DI Package

00852676007049

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case