BD BACTEC™ MGIT™ 960 PZA Medium 245115

GUDID 30382902451151

BD BACTEC™ MGIT™ 960 PZA Medium

BECTON, DICKINSON AND COMPANY

Middlebrook Mycobacteria species broth culture medium IVD
Primary Device ID30382902451151
NIH Device Record Key91539cd2-2dcf-442b-a098-77ec7a11eb62
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD BACTEC™ MGIT™ 960 PZA Medium
Version Model Number245115
Catalog Number245115
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
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 Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter
Total Volume7 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902451150 [Unit of Use]
GS130382902451151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MJASUSCEPTIBILITY TEST POWDERS, ANTIMYCOBACTERIAL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-19

Devices Manufactured by BECTON, DICKINSON AND COMPANY

30382902212400 - BD BBL™ GC II Agar with IsoVitaleX™ Enrichment2024-08-16 BD BBL™ GC II Agar with IsoVitaleX™ Enrichment, Pkg. of 8 plates (150 x 15 mm-style)
30382902212752 - BD BBL™ Mueller Hinton II Agar2024-08-09 BD BBL™ Mueller Hinton II Agar (100 x 15 mm style), Carton of 100 plates
30382902218006 - BD BBL™ Mueller Hinton II Agar2024-08-09 BD BBL™ Mueller Hinton II Agar (150 x 15 mm style), Package of 24 plates
00382904440749 - BD Onclarity™ HPV Extraction Reagent Trough for BD COR™2024-08-05 BD Onclarity™ HPV Extraction Reagent Trough for BD COR™
30382903673231 - BD Vacutainer® Push Button Blood Collection Set2024-07-23 Wingset PBBCS 25x.75 12 w/o Luer
30382903673361 - BD Vacutainer® Push Button Blood Collection Set2024-07-23 WINGSET PBBCS 23X.75 7 LUER
30382903673248 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 Wingset PBBCS 23x.75 12 w/o Luer
30382903673262 - BD Vacutainer® Push Button Blood Collection Set2024-07-16 BD Vacutainer® Push Button Blood Collection Set

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