BD Phoenix™ M50 Automated Microbiology System 443624

GUDID 00382904436247

BD Phoenix™ M50 Automated Microbiology System

BECTON, DICKINSON AND COMPANY

Microorganism identification/antimicrobial-susceptibility analyser IVD, automated
Primary Device ID00382904436247
NIH Device Record Key857096f8-92be-43f7-a562-b0da001bfd87
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Phoenix™ M50 Automated Microbiology System
Version Model Number443624
Catalog Number443624
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 Numbertrue
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
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
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 Dimensions

Depth30 Inch
Depth30 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch
Height21 Inch
Width32 Inch
Depth30 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904436247 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-03-11
Device Publish Date2016-10-17

Devices Manufactured by BECTON, DICKINSON AND COMPANY

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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.