AccessGUDID - DEVICE: BD FACSCanto&#8482; (00382906466006)

GUDID

Device Identifier (DI) Information

Brand Name: BD FACSCanto™
Version or Model: 646600
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 646600
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382906466006
Issuing Agency: GS1
Commercial Distribution End Date: September 20, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: BD FACSCanto System Software V2.4

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
43472	Laboratory instrument/analyser application software IVD	An in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell
OYE	Flow cytometric reagents and accessories.
PER	Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4f127026-d696-45fa-b9b8-a4f685b249c0
Public Version Date: September 25, 2023
Public Version Number: 7
DI Record Publish Date: June 08, 2016