BDXpert™ System 444957

GUDID 00382904449575

BDXpert™ System

BECTON, DICKINSON AND COMPANY

Microorganism identification/antimicrobial-susceptibility analyser IVD
Primary Device ID00382904449575
NIH Device Record Keye118f20e-8c16-4683-96b5-36ddca2ba054
Commercial Distribution StatusIn Commercial Distribution
Brand NameBDXpert™ System
Version Model Number444957
Catalog Number444957
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904449575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-03-28
Device Publish Date2025-03-20

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382904449575 - BDXpert™ System2025-03-28BDXpert™ System
00382904449575 - BDXpert™ System2025-03-28 BDXpert™ System
00382904490829 - NMIC-3122025-03-28 NMIC-312
00382904490836 - NMIC/ID-3132025-03-28 NMIC/ID-313
00382906666482 - N/A2025-03-27 BD® CD26 (M-A261) APC
50382903041423 - N/A2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
30382903884378 - BD Insyte Vialon-E 20GA2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
00382902411154 - BD Francisella tularensis Antigen2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
00382902411161 - BD Francisella tularensis Antisera2025-03-11 Vial F Tularensis Antiserum

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