FDA.reportPublic FDA data

BD BBL™ Crystal™ Identification Systems

Primary DI
00382902450351
Brand
BD BBL™ Crystal™ Identification Systems
Company
BECTON, DICKINSON AND COMPANY
Model
245035
Catalog number
245035
Device description
BD BBL™ Crystal™ Identification Systems
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSTKIT, FASTIDIOUS ORGANISMS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSTKit, Fastidious OrganismsMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902450351PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902450351003829024503513829024503510382902450351

GMDN Terms#

Term, Definition table
TermDefinition
Microorganism identification analyser IVD, manualA mains electricity (AC-powered) laboratory instrument intended to be used for the identification of bacteria and/or yeast isolated from clinical specimens by characterizing their morphology, substrate utilization and/or biochemical reactivity, using growth detection technology which may include immunoassay, colorimetry, chromatography and/or carbon dioxide (CO2) production. The device operates with technician involvement in most procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03573026529710VITEK® 2 NHBIOMERIEUX , INC.JST2020-06-02
03573026144357VITEK® 2 NHBIOMERIEUX , INC.JST2020-06-02
30382902451304BD BBL™ Crystal™ N/HBECTON, DICKINSON AND COMPANYJST2018-05-25