FDA.reportPublic FDA data

BD BBL™ CHROMagar™ O157

Primary DI
10382902149849
Brand
BD BBL™ CHROMagar™ O157
Company
BECTON, DICKINSON AND COMPANY
Model
214984
Catalog number
214984
Device description
BD BBL™ CHROMAgar™ 0157
Published
2018-05-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSICULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070691000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070691000BBL CHROMAGAR 0157Becton, Dickinson & CO2007-11-20JSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902149843PackageGS12Not in Commercial Distribution
10382902149849PrimaryGS10
00382902149842Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290214984330382902149843
1038290214984910382902149849
00382902149842003829021498423829021498420382902149842

GMDN Terms#

Term, Definition table
TermDefinition
Differential/selective agar culture medium IVDAn agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Outer Diameter100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
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