BD BBL™ GC II Agar with IsoVitaleX™ Enrichment 221240

GUDID 30382902212400

BD BBL™ GC II Agar with IsoVitaleX™ Enrichment, Pkg. of 8 plates (150 x 15 mm-style)

BECTON, DICKINSON AND COMPANY

Fastidious-microorganism antimicrobial susceptibility culture medium IVD
Primary Device ID30382902212400
NIH Device Record Key2babbdd2-d69c-4dac-ba47-e1d0e0ebccf8
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD BBL™ GC II Agar with IsoVitaleX™ Enrichment
Version Model Number221240
Catalog Number221240
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count4
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
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

Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter
Outer Diameter150 Millimeter
Depth15 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from light
Special Storage Condition, SpecifyBetween 0 and 0 *Fragile, handle with care
Special Storage Condition, SpecifyBetween 0 and 0 *This way up
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902212409 [Unit of Use]
GS110382902212406 [Primary]
GS130382902212400 [Package]
Contains: 10382902212406
Package: Shelfpack [2 Units]
In Commercial Distribution
GS160382902212401 [Package]
Package: US pallet [1000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JSOCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-08-16
Device Publish Date2016-12-21

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