Catalog Number

-

Brand Name

Calibrant Fluid Pack

Version/Model Number

CP50

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K151978,K151978,K151978

Product Code

JIX

Product Code Name

Calibrator, Multi-Analyte Mixture

Public Device Record Key

9b5e775a-3bbe-41e6-8105-19d18bcf95b5

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 01, 2016

Package DI Number

06944413803145

Quantity per Package

6

Contains DI Package

06944413802599

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-