BD FACSCanto™ - SW FACSCanto II 3.0 no dongle ROW - BECTON, DICKINSON AND COMPANY

Duns Number:024230633

Device Description: SW FACSCanto II 3.0 no dongle ROW

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More Product Details

Catalog Number

659534

Brand Name

BD FACSCanto™

Version/Model Number

659534

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

-

Product Code Details

Product Code

GKZ

Product Code Name

Counter, differential cell

Device Record Status

Public Device Record Key

eafb8be0-851a-4ad7-aff7-2675dbe1c4bd

Public Version Date

March 29, 2018

Public Version Number

2

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