FDA.reportPublic FDA data

BD Phoenix™ NMIC/ID-304

Primary DI
30382904487431
Brand
BD Phoenix™ NMIC/ID-304
Company
BECTON, DICKINSON AND COMPANY
Model
448743
Catalog number
448743
Device description
Panel Phoenix Nmic Id 304
Published
2016-08-30
Public version status
Update
Distribution status
Not 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
K023444000
K023634000
K023858000
K023895000
K024153000
K031530000
K031699000
K031912000
K032299000
K032655000
K032675000
K033458000
K033558000
K033560000
K041384000
K042932000
K052269000
K060214000
K060217000
K060444000
K060447000
K061327000
K061355000
K061867000
K062944000
K063301000
K063573000
K063811000
K063824000
K123266000
K123404000
K132674000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020322000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEMBecton, Dickinson & CO2002-03-27LON
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
K023895000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GNBecton, Dickinson & CO2003-01-08LON
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
K032655000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/MLBecton, Dickinson & CO2003-10-06LON
K032675000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/MLBecton, Dickinson & CO2004-03-01LON
K033458000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TESTBecton, Dickinson & CO2004-05-28LON
K033558000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELSBecton, Dickinson & CO2003-12-19LON
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
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
K061867000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/MLBecton, Dickinson & CO2006-08-10LON
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
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904487431PrimaryGS10
00382904487430Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290448743130382904487431
00382904487430003829044874303829044874300382904487430

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

Sterilization Methods#

Method table
Method

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
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30
00885403522386Swan-Ganz831F75P2026-05-30
00885403523819VAMPVMP400VMP4002026-05-30
00885403524618TruWave, VAMP PlusPXVP2284AT3PXVP2284AT32026-05-30
00885403524717TruWave, VAMP PlusPXVP0566PXVP05662026-05-30
00885403524779TruWave, VAMP PlusPXVP2272PXVP22722026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350136800344ASTar BC G- Kit softwareQ-Linea ABLON2026-05-12
30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
00382904490850NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
03573026615499VITEK® COMPACT PROBIOMERIEUX , INC.LON2025-05-15
03573026618285VITEKBIOMERIEUX , INC.LON2025-05-15
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904449575BDXpert™ SystemBECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490829NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490836NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
10850031114026Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LON2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
10850031114149Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LON2024-12-17
03573026641320VITEK® 2 AST-N815BIOMERIEUX , INC.LON2024-11-13
03573026641337VITEK® 2 AST-N815BIOMERIEUX , INC.LON2024-11-13