FDA.reportPublic FDA data

BD BBL™ Enterococcus Screen Agar QUAD Plate

Primary DI
10382902222016
Brand
BD BBL™ Enterococcus Screen Agar QUAD Plate
Company
BECTON, DICKINSON AND COMPANY
Model
222201
Catalog number
222201
Device description
BD BBL™ Enterococcus Screen Agar
Published
2016-12-21
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
JWYManual antimicrobial susceptibility test systems

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JWYManual Antimicrobial Susceptibility Test SystemsMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951539000ENTEROCOCCUS SCREENING MEDIUMBecton Dickinson Microbiology Systems1995-06-13JWY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382902222010PackageGS11Not in Commercial Distribution
10382902222016PrimaryGS10
00382902222019Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290222201030382902222010
1038290222201610382902222016
00382902222019003829022220193829022220190382902222019

GMDN Terms#

Term, Definition table
TermDefinition
Multiple formulation agar culture medium IVDA combination of two or more selective, differential and/or enriched agar culture media formulations separately contained within a single petri dish (commonly referred to as a split plate) or dip slide and intended to be used for the simultaneous growth, selective isolation and/or differentiation of microorganisms from a clinical specimen.

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
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
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30

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