BD Phoenix™ AST Indicator Solution 246004

GUDID 30382902460047

BD Phoenix™ AST Indicator Solution

BECTON, DICKINSON AND COMPANY

Multiple antibacterial minimum inhibitory concentration (MIC) IVD, reagent
Primary Device ID30382902460047
NIH Device Record Keyb0513985-441c-4518-aa7d-a4c97edfcded
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Phoenix™ AST Indicator Solution
Version Model Number246004
Catalog Number246004
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
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Device Dimensions

Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter
Total Volume6 Milliliter

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
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
GS100382902460046 [Unit of Use]
GS130382902460047 [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 Number4
Public Version Date2019-01-23
Device Publish Date2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

10382902212673 - BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2026-02-27 BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and BD IsoVitaleX™), Ctn. of 100 plates
30382903836483 - Nexiva2026-02-25 BD Nexiva™ Closed IV Catheter System 20GA x 1.75IN (Dual Port w/Cap)
30382903810124 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 24 GA x 0.75 IN
30382903810230 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.00 IN
30382903810247 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.25 IN
30382903810339 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.00 IN
30382903810346 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.16 IN
30382903810377 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.88 IN

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.