FDA.reportPublic FDA data

BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)

Primary DI
10382902211690
Brand
BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)
Company
BECTON, DICKINSON AND COMPANY
Model
221169
Catalog number
221169
Device description
BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)
Published
2016-12-21
Public version status
Update
Distribution status
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
KZICULTURE MEDIA, ENRICHED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZICulture Media, EnrichedMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10382902211690PrimaryGS10
00382902211693Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1038290221169010382902211690
00382902211693003829022116933829022116930382902211693

GMDN Terms#

Term, Definition table
TermDefinition
Enriched agar culture medium IVDAn agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth15Millimeter
Outer Diameter100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
10
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
10382902218088BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
30382902218082BD BBL™ BCYE AgarBECTON, DICKINSON AND COMPANYKZI2024-09-19
00850056467063Schaedler Blood Agar OxyPlateOxyrase, Inc.KZI2023-11-30
00810144911120RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911144RediporAnalytiChem USA, Inc.KZI2023-09-21
00810144911151RediporAnalytiChem USA, Inc.KZI2023-09-21
05051716000155AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
05051716000162AIM-V MediumOxford Immunotec, Inc.KZI2023-02-07
00848838001505REMELREMEL, INC.KZI2023-01-04
00848838010965REMELREMEL, INC.KZI2023-01-04
00848838010972REMELREMEL, INC.KZI2023-01-04
00848838012136REMELREMEL, INC.KZI2023-01-04
00848838012174REMELREMEL, INC.KZI2023-01-04
00819398020565N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398020558N/AHARDY DIAGNOSTICSKZI2022-07-25
00819398028431N/AHARDY DIAGNOSTICSKZI2020-09-02
00816576027576N/AHARDY DIAGNOSTICSKZI2020-06-08
00816576027613N/AHARDY DIAGNOSTICSKZI2020-06-08
00819398024228HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024242HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024266HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00819398024235HardyFlask™HARDY DIAGNOSTICSKZI2020-06-08
00816576027262N/AHARDY DIAGNOSTICSKZI2020-06-05
00816576027477N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023535N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398023528N/AHARDY DIAGNOSTICSKZI2020-06-05
00819398022194N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022293N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398028127N/AHARDY DIAGNOSTICSKZI2020-06-03
00819398022187N/AHARDY DIAGNOSTICSKZI2020-06-03