AccessGUDID - DEVICE: BD FACSCalibur™ (00382903429752)

GUDID

Device Identifier (DI) Information

Brand Name: BD FACSCalibur™
Version or Model: 342975
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 342975
Company Name: BECTON, DICKINSON AND COMPANY

Primary DI Number: 00382903429752
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 024230633 *Terms of Use

Device Description: FACSCalibur Cytometer 4 Color Basic IVD

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Flow cytometry analyser IVD, automated	A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with minimal technician involvement and complete automation of all procedural steps.

GMDN Preferred Term Name

GMDN Definition

Flow cytometry analyser IVD, automated

A mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with minimal technician involvement and complete automation of all procedural steps.

FDA Product Code

[?]

Product Code	Product Code Name
GKZ	Counter, differential cell

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K923790	000

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: 7fb0dd81-5673-480b-b076-4bd6407cabd3
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: June 08, 2016