BD Phoenix™ SMIC-101

Basic Information

• Brand Name: BD Phoenix™ SMIC-101
• Primary DI: 30382904488032
• Version / Model: 448803
• Catalog Number: 448803
• Company Name: BECTON, DICKINSON AND COMPANY
• Labeler DUNS: 122561087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-05-19
• Public Version: 5
• Public Version Date: 2023-10-23
• Public Version Status: Update
• Public Device Record Key: fd3a0566-f671-4d56-ad32-b6bb161afd3d

Device Description

BD Phoenix™ SMIC-101

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
43554	Bacterial 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 bacteria 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	30382904488032	GS1
Unit of Use	00382904488031	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K032675	000
K050745	000
K050747	000
K050780	000
K050865	000
K050881	000
K050946	000
K050982	000
K051109	000
K051138	000
K051204	000
K051266	000
K051272	000
K051692	000
K062206	000

Storage Conditions

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