FDA.reportPublic FDA data

BD BACTEC™ FXI Culture System Analyzer Module

Primary DI
00382904453503
Brand
BD BACTEC™ FXI Culture System Analyzer Module
Company
BECTON, DICKINSON AND COMPANY
Model
445350
Catalog number
445350
Device description
BD BACTEC™ FXI Culture System Analyzer Module
Published
2026-06-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
MDBSystem, blood culturing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDBSystem, Blood CulturingMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260213000BD BACTEC FXI Culture SystemBD Diagnostic Systems2026-05-28MDB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904453503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904453503003829044535033829044535030382904453503

GMDN Terms#

Term, Definition table
TermDefinition
Blood culture analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro determination of microorganism growth in a blood culture preparation or other clinical specimen, with or without subsequent identification of the organism. Changes in metabolite production which indicate growth may be detected using radiometric labelled substrate uptake, infrared spectrophotometric detection of CO2, fluorometric detection of fluorescent substrate uptake, photometric detection of turbidity change and/or colorimetric detection of pH induced colour change.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth0
Height0
Weight0
Width0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00RH (non-condensing)
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
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
00885403524809TruWave, VAMP PlusPXVP2284PXVP22842026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904453497BD BACTEC™ FXI Culture System Workflow ModuleBECTON, DICKINSON AND COMPANYMDB2026-06-02
00382902451228BD BACTEC™ MGIT™ Mycobacteria Growth Indicator TubesBECTON, DICKINSON AND COMPANYMDB2026-01-07
00382904422882BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
60382904422884BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2025-02-07
00848838091841VersaTREK™ REMEL, INC.MDB2025-01-16
00848838091742VersaTREK™ REMEL, INC.MDB2025-01-16
00382904454753BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904455705BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904454755BD BACTEC™ 9240BECTON, DICKINSON AND COMPANYMDB2024-11-04
60382904455707BD BACTEC™ 9120BECTON, DICKINSON AND COMPANYMDB2024-11-04
00382904458003BD BACTEC™ 9050BECTON, DICKINSON AND COMPANYMDB2024-11-01
00382904458713BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904459994BD BACTEC™ MGIT™ 960 Calibration VialBECTON, DICKINSON AND COMPANYMDB2024-08-29
00382904413705BD BACTEC™ Digital ThermometerBECTON, DICKINSON AND COMPANYMDB2024-08-22
00848838096747VERSATREK M 528 W/22 DRAWERSREMEL, INC.MDB2023-09-19
03573026629649BACT/ALERTBIOMERIEUX , INC.MDB2023-09-15
00848838096327VERSATREK 528 W/22 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096471VERSATREK 240 W/6 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096501VERSATREK 240 W/8 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096518VERSATREK 240 W/8 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-26
00848838096549VERSATREK 240 W/10 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096556VERSATREK 240 W/10 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
00848838096570VERSATREK 528 W/14 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-26
00848838096617 VERSATREK 528 W/16 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
00848838096655VERSATREK 528 W/18 DRAWERS/CTRL MOD REMEL, INC.MDB2023-07-26
00848838096662VERSATREK 528 W/18 DR/CTRL MOD 220VREMEL, INC.MDB2023-07-26
00848838096693VERSATREK 528 W/20 DRAWERS/CTRL MREMEL, INC.MDB2023-07-26
00848838096426VERSATREK 240 W/4 DRAWERS/CTRL MODREMEL, INC.MDB2023-07-25
00848838096433 VERSATREK 240 W/4 DR/CTRL MOD, 220VREMEL, INC.MDB2023-07-25
30382904427949BD BACTEC™ Myco/F Lytic Culture VialsBECTON, DICKINSON AND COMPANYMDB2023-06-13