BD BACTEC™ MGIT™ 960 System 445870

GUDID 00382904458706

BD BACTEC™ MGIT™ 960 System

BECTON, DICKINSON AND COMPANY

Blood culture analyser IVD, automated

Primary Device ID	00382904458706
NIH Device Record Key	3229be39-4d70-48be-827a-c295cecfc478
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD BACTEC™ MGIT™ 960 System
Version Model Number	445870
Catalog Number	445870
Company DUNS	122561087
Company Name	BECTON, DICKINSON AND COMPANY
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com
Phone	+1(800)638-8663
Email	Technical_services@bd.com

Device Dimensions

Height	53 Inch
Height	53 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch
Width	36 Inch
Depth	32 Inch
Height	53 Inch

Operating and Storage Conditions

Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 19 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904458706 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K974883

FDA Product Code

MDB	SYSTEM, BLOOD CULTURING

Sterilization

Steralize Prior To Use	false
Device Is Sterile	false

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	2
Public Version Date	2018-07-06
Device Publish Date	2018-05-25

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