BD BACTEC™ MGIT™ 320 System 441743

GUDID 00382904417437

BD BACTEC™ MGIT™ 320 System

BECTON, DICKINSON AND COMPANY

Blood culture analyser IVD, automated
Primary Device ID00382904417437
NIH Device Record Key5b5eba16-9c8f-47f3-83c9-7cf639128b64
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD BACTEC™ MGIT™ 320 System
Version Model Number441743
Catalog Number441743
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

Device Dimensions

Height25 Inch
Height25 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch
Width36 Inch
Depth28.5 Inch
Height25 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 19 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904417437 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MDBSYSTEM, BLOOD CULTURING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-25

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