Phoenix Diagnostics - K Calibrator for Roche / Hitachi Chemistry Systems - PHOENIX DIAGNOSTICS, INC.

Duns Number:606814960

Device Description: K Calibrator for Roche / Hitachi Chemistry Systems

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More Product Details

Catalog Number

16-218

Brand Name

Phoenix Diagnostics

Version/Model Number

16-218

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K013451,K013451

Product Code Details

Product Code

JIT

Product Code Name

Calibrator, Secondary

Device Record Status

Public Device Record Key

652f67f5-9519-4243-86d7-19981af8f526

Public Version Date

March 30, 2020

Public Version Number

4

DI Record Publish Date

April 26, 2017

Additional Identifiers

Package DI Number

10853366007285

Quantity per Package

10

Contains DI Package

00853366007288

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"PHOENIX DIAGNOSTICS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 37