FDA.reportPublic FDA data

BD BBL™ Gram Decolorizer

Primary DI
00382902125280
Brand
BD BBL™ Gram Decolorizer
Company
BECTON, DICKINSON AND COMPANY
Model
212528
Catalog number
212528
Device description
BD BBL™ Gram Decolorizer, 3.8 L
Published
2018-05-25
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
JTSStains, microbiologic
LEDSTAINS, CHEMICAL SOLUTION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JTSStains, MicrobiologicHematology1
LEDStains, Chemical SolutionHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382902125280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382902125280003829021252803829021252800382902125280

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain solution kit IVDA collection of chemical agents, dyes and/or solutions intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms in a clinical specimen for subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3.8Liter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 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
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10673486014105Teco Diagnostics Hema StainTECO DIAGNOSTICSJTS2026-07-31
00630414290010Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00630414312484Atellica HEMA RET/PLTOSiemens Healthcare Diagnostics Inc.LED2026-02-06
00613647028643FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
20613647028647FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.LED2025-04-30
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