BD Phoenix™ NMIC-311 449452

GUDID 00382904494520

BD Phoenix™ NMIC-311

BECTON, DICKINSON AND COMPANY

Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, reagent
Primary Device ID00382904494520
NIH Device Record Key738b8263-e38a-49d5-b347-5874040e1c1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Phoenix™ NMIC-311
Version Model Number449452
Catalog Number449452
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count25
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904494520 [Unit of Use]
GS130382904494521 [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 Date2024-09-06
Device Publish Date2024-08-29

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382902604679 - BD BBL ™ GasPak™ 100 Vented Lid2024-09-06 BD BBL ™ GasPak™ 100 Vented Lid
00382904440640 - BD Kiestra™ ID AST Calibrator Kit2024-09-06 BD Kiestra™ ID AST Calibrator Kit
00382904441395 - BD Synapsys™ Informatics Solution2024-09-06 BD Synapsys™ Informatics Solution
00382904458713 - BD BACTEC™ MGIT™ 960 Calibration Vial2024-09-06 BD BACTEC™ MGIT™ 960 Calibration Vial, 17 pack
00382904459994 - BD BACTEC™ MGIT™ 960 Calibration Vial2024-09-06 BD BACTEC™ MGIT™ 960 Calibration Vial, 51 pack
30382902981917 - BD BBL™ Inhibitory Mold Agar Deep Fill2024-09-06 BD BBL™ Inhibitory Mold Agar Deep Fill
00382904490362 - Panel Phoenix PMIC-1102024-09-06 Panel Phoenix PMIC-110
00382904494520 - BD Phoenix™ NMIC-3112024-09-06BD Phoenix™ NMIC-311
00382904494520 - BD Phoenix™ NMIC-3112024-09-06 BD Phoenix™ NMIC-311

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.