FDA.reportPublic FDA data

BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid

Primary DI
30382902450383
Brand
BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid
Company
BECTON, DICKINSON AND COMPANY
Model
245038
Catalog number
245038
Device description
BD BBL™ Crystal™ ANR, GP, RGP, N/H ID Inoculum Fluid
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
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JSPKIT, ANAEROBIC IDENTIFICATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JSPKit, Anaerobic IdentificationMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902450383PrimaryGS10
00382902450382Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290245038330382902450383
00382902450382003829024503823829024503820382902450382

GMDN Terms#

Term, Definition table
TermDefinition
Inoculation fluid IVDA solution intended to be used to re-suspend and dilute an isolated pure microbial culture from a clinical specimen, in preparation for subsequent testing. The solution is intended to rehydrate dried biochemical and enzymatic substrates to initiate test reactions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius25 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
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00382905167508BD Intelliport5167505167502020-09-30
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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
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05032384028528PET RPLA KITOXOID LIMITEDJSP2022-12-04
15099590655907MicroScanBeckman Coulter, Inc.JSP2022-11-15
15099590655983MicroScanBeckman Coulter, Inc.JSP2022-11-15
00848838058035Remel REMEL, INC.JSP2021-11-12
30848838058036Remel REMEL, INC.JSP2021-11-12
03848838058032Remel REMEL, INC.JSP2021-11-12
03573026529727VITEK® 2 ANCBIOMERIEUX , INC.JSP2020-06-02
03573026144364VITEK® 2 ANCBIOMERIEUX , INC.JSP2020-06-02
03573026588564RAPID ID 32 ABIOMERIEUX SAJSP2020-04-10
03573026048150API® 20 ABIOMERIEUX SAJSP2020-04-10
03573026066420rapid ID 32 ABIOMERIEUX SAJSP2020-04-10
30382902450109BD BBL™ Crystal™ ANRBECTON, DICKINSON AND COMPANYJSP2018-05-25
00382902450115BD BBL™ Crystal™ ID Systems Anaerobe Manual CodebookBECTON, DICKINSON AND COMPANYJSP2018-05-25