FDA.reportPublic FDA data

BD BBL™ TB Decolorizer TM

Primary DI
30382902125120
Brand
BD BBL™ TB Decolorizer TM
Company
BECTON, DICKINSON AND COMPANY
Model
212512
Catalog number
212512
Device description
BD BBL™ TB Decolorizer TM, 4 x 250 mL
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
30382902125120PackageGS14In Commercial Distribution
00382902125129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290212512030382902125120
00382902125129003829021251293829021251290382902125129

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain 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 Volume250Milliliter

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
4
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
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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
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00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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