FDA.reportPublic FDA data

BD Phoenix™ NMIC/ID-128

Primary DI
30382904487288
Brand
BD Phoenix™ NMIC/ID-128
Company
BECTON, DICKINSON AND COMPANY
Model
448728
Catalog number
448728
Device description
BD Phoenix™ NMIC/ID-128
Published
2016-08-09
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
K022129000
K023444000
K023634000
K023858000
K031429000
K031530000
K031699000
K032153000
K032299000
K032655000
K033458000
K041384000
K041572000
K042932000
K043389000
K052269000
K060217000
K060444000
K060447000
K061327000
K061355000
K062944000
K063301000
K063573000
K063811000
K063824000

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
K031429000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/MLBd Diagnostic Systems2003-06-06LON
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
K032153000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFOTAXIME 0.5-64 UG/MLBd Diagnostic Systems2003-09-11LON
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
K033458000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TESTBecton, Dickinson & CO2004-05-28LON
K041384000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVEBecton, Dickinson & CO2004-08-03LON
K041572000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERCILLIN (GN) 0.5-128 UG/MLBecton, Dickinson and Co.2004-08-12LON
K042932000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/MLBecton, Dickinson & CO2004-12-02LON
K043389000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/MLBecton, Dickinson & CO2005-01-21LON
K052269000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GNBecton, Dickinson & CO2005-10-03LON
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904487288PrimaryGS10
00382904487287Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290448728830382904487288
00382904487287003829044872873829044872870382904487287

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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

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15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
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15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.LON2025-12-08
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
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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
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00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20
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