BD FACSCanto™ - FACSCanto II 3.0 SW without dongle - BECTON, DICKINSON AND COMPANY

Duns Number:024230633

Device Description: FACSCanto II 3.0 SW without dongle

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More Product Details

Catalog Number

657880

Brand Name

BD FACSCanto™

Version/Model Number

657880

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

K062087

Product Code Details

Product Code

GKZ

Product Code Name

Counter, differential cell

Device Record Status

Public Device Record Key

55a786f0-8f53-4bc6-aa00-eca20f9c99e6

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

June 08, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BECTON, DICKINSON AND COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 611
2 A medical device with a moderate to high risk that requires special controls. 614
3 A medical device with high risk that requires premarket approval 36
U Unclassified 4