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
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LIEREAGENT/DEVICE, INOCULUM CALIBRATION

Product Code Classifications#

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

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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
60
DM exempt
false
Premarket exempt
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

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