BD BACTEC™ 9240 445475

GUDID 60382904454755

BD BACTEC™ 9240

BECTON, DICKINSON AND COMPANY

Blood culture analyser IVD

Primary Device ID	60382904454755
NIH Device Record Key	7473ab8f-df7e-4722-81ab-17de49cfd8bf
Commercial Distribution Status	In Commercial Distribution
Brand Name	BD BACTEC™ 9240
Version Model Number	445475
Catalog Number	445475
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
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

Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter
Width	132 Centimeter
Height	96.5 Centimeter
Depth	57.2 Centimeter

Operating and Storage Conditions

Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 18 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382904454753 [Primary]
GS1	60382904454755 [Package] Contains: 00382904454753 Package: US pallet [1 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K915796

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	1
Public Version Date	2024-11-12
Device Publish Date	2024-11-04

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382904449575 - BDXpert™ System	2025-03-28 BDXpert™ System
00382904490829 - NMIC-312	2025-03-28 NMIC-312
00382904490836 - NMIC/ID-313	2025-03-28 NMIC/ID-313
00382906666482 - N/A	2025-03-27 BD® CD26 (M-A261) APC
50382903041423 - N/A	2025-03-25 NEEDLE 23GA 1-1/2IN BNS TW
30382903884378 - BD Insyte Vialon-E 20GA	2025-03-25 INSYTE VIALON-E 20GA X 1.88IN
00382902411154 - BD Francisella tularensis Antigen	2025-03-11 Vial Francisella Tularensis Antigen 5 Ml
00382902411161 - BD Francisella tularensis Antisera	2025-03-11 Vial F Tularensis Antiserum