BD Phoenix™ EMERGE AST Broth

Basic Information

• Brand Name: BD Phoenix™ EMERGE AST Broth
• Primary DI: 30382902460160
• Version / Model: 246016
• Catalog Number: 246016
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2021-02-15
• Public Version: 1
• Public Version Date: 2021-02-23
• Public Version Status: New
• Public Device Record Key: ce962738-2985-48a0-8867-1d630f63a965

Device Description

AST Broth 12.5ml - Emerge

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: 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
LON	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION	Microbiology	866.1645	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43534	Multiple antibacterial minimum inhibitory concentration (MIC) 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 degree of susceptibility or the minimum inhibitory concentration (MIC) of a range of antibacterial/antibiotic agents (i.e., a drug intended for treatment and/or prevention of a bacterial infection, excluding mycobacterial infection) against a specific bacterial microorganism, isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00382902460169	GS1
Primary	30382902460160	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K020321	000

Storage Conditions

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