BD FACSuite

Basic Information

• Brand Name: BD FACSuite
• Primary DI: 00382906650061
• Version / Model: 665006
• Catalog Number: 665006
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 024230633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 2
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 5021ab6f-1acd-4b34-b3e6-df7fed53ff1f

Device Description

BD FACSuite™ Clinical BD® Stem Cell Enumeration Assay Module

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OYE	Flow cytometric reagents and accessories.	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55858	White blood cell count IVD, kit, cell count	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative determination of the white blood cell (leukocyte) count and/or the differential of white cell types in a clinical specimen using a manual, semi-automated or automated cell count method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382906650061	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Room Temperature