BD PhoenixSpec™ Calibrator Kit

Basic Information

• Brand Name: BD PhoenixSpec™ Calibrator Kit
• Primary DI: 00382904409111
• Version / Model: 440911
• Catalog Number: 440911
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-25
• Public Version: 1
• Public Version Date: 2018-06-25
• Public Version Status: New
• Public Device Record Key: 53fe00cd-4950-41a3-aa47-aa8ca141f9c7

Device Description

BD PhoenixSpec™ Calibrator Kit

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: Yes
• 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
JQX	NEPHELOMETER, FOR CLINICAL USE	Clinical Chemistry	862.2700	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57870	Microorganism-density nephelometer IVD	A mains electricity (AC-powered) laboratory instrument intended to be used to determine the density of microorganism suspensions by comparing the turbidity of a solution with that of McFarland standards using a photometric detection system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00382904409111	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 20 – 30 Degrees Celsius