Catalog Number

342974

Brand Name

BD FACSCalibur

Version/Model Number

342974

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

-

Product Code

GKZ

Product Code Name

Counter, differential cell

Public Device Record Key

ad8273a0-72ff-48cf-afef-607a65d3d6af

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

June 08, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-