FDA.reportPublic FDA data

BD BBL™ Sensi-Disc™ Single Disc Dispenser

Primary DI
30382902604595
Brand
BD BBL™ Sensi-Disc™ Single Disc Dispenser
Company
BECTON, DICKINSON AND COMPANY
Model
260459
Catalog number
260459
Device description
BD BBL™ Sensi-Disc™ Single Disc Dispenser
Published
2016-05-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JTNSUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL
LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTNSusceptibility Test Discs, AntimicrobialMicrobiology2
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902604595PrimaryGS10
00382902604594Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290260459530382902604595
00382902604594003829026045943829026045940382902604594

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial sensitivity disc dispenser IVDA manually-operated IVD intended to be used for the storage and/or dispensing of antimicrobial sensitivity discs impregnated with antimicrobial agents onto agar or other culture media, for the antimicrobial susceptibility testing of culture isolates from clinical laboratory specimens.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
6
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

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