BD Trucount

Basic Information

• Brand Name: BD Trucount
• Primary DI: 00382903403349
• Version / Model: 340334
• Catalog Number: 340334
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 024230633
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-08
• Public Version: 10
• Public Version Date: 2023-10-09
• Public Version Status: Update
• Public Device Record Key: 7d1748fc-ccbf-42b9-acdb-2bf36420bc65

Device Description

BD Trucount™ Tubes

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKZ	Counter, differential cell	Hematology	864.5220	2
OYE	Flow cytometric reagents and accessories.	Hematology	864.5220	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55859	White blood cell count IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382903403349	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 25 Degrees Celsius