FDA.report

BD BBL™ Hektoen Enteric Agar

Primary DI
10382902213656
Brand
BD BBL™ Hektoen Enteric Agar
Company
BECTON, DICKINSON AND COMPANY
Model
221365
Catalog number
221365
Device description
BD BBL™ Hektoen Enteric Agar
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
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
JSICULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

Product Code Classifications

CodeDeviceSpecialtyClass
JSICulture Media, Selective And DifferentialMicrobiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
30382902213650PackageGS12Not in Commercial Distribution
60382902213651PackageGS1400Not in Commercial Distribution
10382902213656PrimaryGS10
00382902213659Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290221365030382902213650
6038290221365160382902213651
1038290221365610382902213656
00382902213659003829022136593829022136590382902213659

GMDN Terms

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

TypeValueUnit
Depth15Millimeter
Outer Diameter100Millimeter

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags

DUNS number
122561087
Device count
10
DM exempt
false
Premarket exempt
true
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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