FDA.reportPublic FDA data

BD BBL™ Prompt™ Inoculation System

Primary DI
30382902263068
Brand
BD BBL™ Prompt™ Inoculation System
Company
BECTON, DICKINSON AND COMPANY
Model
226306
Catalog number
226306
Device description
BD BBL™ Prompt™ Inoculation System
Published
2016-04-29
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
LIEREAGENT/DEVICE, INOCULUM CALIBRATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIEReagent/Device, Inoculum CalibrationMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820299000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820299000PROMPT INOCULATION SYSTEM3M Company1982-03-15LIE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902263068PrimaryGS10
00382902263067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290226306830382902263068
00382902263067003829022630673829022630670382902263067

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
Storage Environment Temperature2 Degrees Celsius27 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
60
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382905167065BD Intelliport5167065167062020-09-30
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
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
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05032384497409Sensititre AIM™TREK DIAGNOSTIC SYSTEMS LIMITEDLIE2023-09-22
00848838097409THE SENSITITRE AIMREMEL, INC.LIE2023-06-20
15099590659561MicroScan PROMPTBeckman Coulter, Inc.LIE2016-09-23