FDA.reportPublic FDA data

BD Phoenix™ NMIC-311

Primary DI
30382904494521
Brand
BD Phoenix™ NMIC-311
Company
BECTON, DICKINSON AND COMPANY
Model
449452
Catalog number
449452
Device description
BD Phoenix™ NMIC-311
Published
2024-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020322000
K022129000
K023444000
K023634000
K023858000
K024153000
K031530000
K031699000
K031912000
K032299000
K032567000
K032655000
K033362000
K033458000
K033560000
K041384000
K042932000
K052269000
K060214000
K060217000
K060257000
K060444000
K060447000
K061327000
K061355000
K062207000
K062944000
K063301000
K063486000
K063573000
K063811000
K063824000
K071623000
K123266000
K123404000
K132674000
K132909000
K151320000
K163637000
K173252000
K173523000
K190905000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020322000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEMBecton, Dickinson & CO2002-03-27LON
K022129000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/MLBecton, Dickinson & CO2002-07-25LON
K023444000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/MLBecton, Dickinson & CO2002-11-12LON
K023634000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML)Becton, Dickinson & CO2002-12-24LON
K023858000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEMBecton, Dickinson & CO2002-12-20LON
K024153000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/MLBecton, Dickinson & CO2003-02-10LON
K031530000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/MLBecton, Dickinson & CO2003-07-10LON
K031699000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/MLBecton, Dickinson & CO2003-07-30LON
K031912000BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/MLBecton, Dickinson & CO2003-07-21LON
K032299000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/MLBecton, Dickinson & CO2003-09-22LON
K032567000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVEBecton, Dickinson & CO2003-09-17LON
K032655000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/MLBecton, Dickinson & CO2003-10-06LON
K033362000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVEBecton, Dickinson & CO2004-04-09LON
K033458000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TESTBecton, Dickinson & CO2004-05-28LON
K033560000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELSBecton, Dickinson & CO2004-01-14LON
K041384000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVEBecton, Dickinson & CO2004-08-03LON
K042932000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/MLBecton, Dickinson & CO2004-12-02LON
K052269000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GNBecton, Dickinson & CO2005-10-03LON
K060214000BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/MLBecton, Dickinson & CO2006-03-09LON
K060217000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/MLBecton, Dickinson & CO2006-04-12LON
K060257000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/MLBecton, Dickinson & CO2006-04-14LON
K060444000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/MLBecton, Dickinson & CO2006-04-12LON
K060447000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN)Becton, Dickinson & CO2006-04-26LON
K061327000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0.Becton, Dickinson & CO2006-07-03LON
K061355000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/MLBecton, Dickinson & CO2006-06-07LON
K062207000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/MLBecton, Dickinson & CO2006-09-13LON
K062944000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/MLBecton, Dickinson & CO2006-11-15LON
K063301000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/MLBecton, Dickinson & CO2006-12-08LON
K063486000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLYBecton, Dickinson & CO2007-03-07LON
K063573000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/MLBecton, Dickinson & CO2007-01-11LON
K063811000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/MLBecton, Dickinson & CO2007-02-09LON
K063824000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/MLBecton, Dickinson & CO2007-02-14LON
K071623000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/MLBecton, Dickinson & CO2007-08-20LON
K123266000BD PHOENIX AUTOMATED MICROIOLOGY SYSTEM- ERTAPENEM 0.0625-8 UG/ML-GNBecton, Dickinson and Company2013-06-26LON
K123404000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML)Becton, Dickinson & CO2013-06-27LON
K132674000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- MEROPENEM (0.125-32 UG/ML)Becton, Dickinson and Company2013-12-27LON
K132909000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TIGECYCLINE (0.25-16 UG/ML)Becton, Dickinson and Company2014-02-14LON
K151320000BD Phoenix Automated Microbiology System-Ertapenem 0.0625-8 mcg/mlBecton, Dickinson and Company2016-01-15LON
K163637000BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)Becton Dickinson & Company2017-03-21LON
K173252000BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL)Becton, Dickinson and Company2018-01-05LON
K173523000BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL)Becton, Dickinson and Company2018-02-09LON
K190905000BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL)Becton, Dickinson and Company2019-07-01LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904494521PrimaryGS10
00382904494520Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290449452130382904494521
00382904494520003829044945203829044945200382904494520

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagentA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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Primary DI, Brand, Company table
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