FDA.reportPublic FDA data

BD BBL™ Malonate Broth, Ewing Modified

Primary DI
30382902213223
Brand
BD BBL™ Malonate Broth, Ewing Modified
Company
BECTON, DICKINSON AND COMPANY
Model
221322
Catalog number
221322
Device description
BD BBL™ Malonate Broth, Ewing Modified
Published
2018-05-25
Public version status
Update
Distribution status
Not 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
JSHCULTURE MEDIA, NON-SELECTIVE AND DIFFERENTIAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSHCulture Media, Non-Selective And DifferentialMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902213223PrimaryGS10
00382902213222Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290221322330382902213223
00382902213222003829022132223829022132220382902213222

GMDN Terms#

Term, Definition table
TermDefinition
Enterobacteriaceae agar culture medium IVDA selective and/or differential agar culture medium intended to be used for the growth and differentiation of coliform bacteria and Enterobacteriaceae from a clinical specimen using lactose and/or sucrose fermentation. It typically consists of formulations containing dye compounds [e.g., eosin methylene blue (EMB), fuchsin sulphite (Endo), crystal violet and bromothymol blue (Drigalski)] which inhibit growth of gram positive bacteria and result in coloration of the agar and/or colonies.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24

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