BD Phoenix™ Yeast ID

Basic Information

• Brand Name: BD Phoenix™ Yeast ID
• Primary DI: 30382904483167
• Version / Model: 448316
• Catalog Number: 448316
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• 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: b166e317-7b57-497e-be48-3f02bb5c6aec

Device Description

BD Phoenix™ Yeast ID

Device Characteristics

• Single Use: Yes
• 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
JXB	KIT, IDENTIFICATION, YEAST	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
36262	Yeast species culture isolate identification/antimicrobial susceptibility profile 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 to determine the identification and antimicrobial susceptibility profile of a Yeast species isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30382904483167	GS1
Unit of Use	00382904483166	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius