BD Phoenix™ EMERGE AST Indicator Solution 246015

GUDID 00382902460152

AST Indicator Emerge

BECTON, DICKINSON AND COMPANY

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent
Primary Device ID00382902460152
NIH Device Record Key495b72c0-27c9-4198-b645-72d095fdafcd
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Phoenix™ EMERGE AST Indicator Solution
Version Model Number246015
Catalog Number246015
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count10
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902460152 [Unit of Use]
GS130382902460153 [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 Date2021-02-23
Device Publish Date2021-02-15

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