BD SurePath™ Collection Vial

Primary DI
10382904914520
Brand
BD SurePath™ Collection Vial
Company
BECTON, DICKINSON AND COMPANY
Model
491452
Catalog number
491452
Device description
BD SurePath™ Collection Vial
Published
2018-08-23
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
MKQProcessor, cervical cytology slide, automated

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MKQProcessor, Cervical Cytology Slide, AutomatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970018032

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970018032BD PREPSTAIN SYSTEMBd Diagnostic Systems1999-06-17MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904914524PackageGS120In Commercial Distribution
10382904914520PrimaryGS10
00382904914523Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290491452430382904914524
1038290491452010382904914520
00382904914523003829049145233829049145230382904914523

GMDN Terms#

Term, Definition table
TermDefinition
Cytology specimen container IVD, transport bufferA covered receptacle containing transport buffer solution intended to be used for the collection, preservation, and transport of a cytology specimen (e.g., oral, cervical, colonic) for in vitro diagnostic investigation [e.g., histopathological cervical cancer screening]. It does not contain patient-contact specimen sampling/extraction devices such as swabs/brushes. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

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

Regulatory Flags#

DUNS number
122561087
Device count
25
Kit
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
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00382904003722BD Whitacre Spinal4003724003722023-09-02
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15420045513952ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
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30382904914524BD SurePath™ Collection VialBECTON, DICKINSON AND COMPANYMKQ2018-08-23
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00382904912888BD PrepMate™ Installation KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912895BD PrepStain™ Install KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904913069BD Density ReagentTRIPATH IMAGING, INC.MKQ2017-09-08
00382904913113BD PrepStain™ Consumables KitTRIPATH IMAGING, INC.MKQ2017-09-08
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