BD BBL™ GC II Agar with IsoVitaleX™ Enrichment

Primary DI
30382902212400
Brand
BD BBL™ GC II Agar with IsoVitaleX™ Enrichment
Company
BECTON, DICKINSON AND COMPANY
Model
221240
Catalog number
221240
Device description
BD BBL™ GC II Agar with IsoVitaleX™ Enrichment, Pkg. of 8 plates (150 x 15 mm-style)
Published
2016-12-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSOCULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, EXCLUDING MUELLER HINTON AGAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSOCulture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton AgarMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K945569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K945569000GCII AGAR WITH ISOVITALX(R) ENRICHMENTBecton Dickinson Microbiology Systems1995-02-02JSO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902212400PackageGS12In Commercial Distribution
60382902212401PackageGS11000In Commercial Distribution
10382902212406PrimaryGS10
00382902212409Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290221240030382902212400
6038290221240160382902212401
1038290221240610382902212406
00382902212409003829022124093829022124090382902212409

GMDN Terms#

Term, Definition table
TermDefinition
Fastidious-microorganism antimicrobial susceptibility culture medium IVDA supplemented culture medium enriched with blood and/or other additives intended to be used to perform diagnostic antimicrobial susceptibility testing on fastidious microorganisms isolated from a clinical specimen.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Outer Diameter150Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Fragile, handle with care
Special Storage Condition, Specify00Keep away from light
Special Storage Condition, Specify00This way up
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
4
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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