BD Settling Chambers

Primary DI
30382904913299
Brand
BD Settling Chambers
Company
TRIPATH IMAGING, INC.
Model
491329
Catalog number
491329
Device description
BD Settling Chambers (96). Consumables for use on the PrepStain instrument.
Published
2015-05-05
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
MKQProcessor, Cervical Cytology Slide, Automated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970018000BD PREPSTAIN SYSTEMBd Diagnostic Systems1999-06-17MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904913299PrimaryGS10
00382904913298Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290491329930382904913299
00382904913298003829049132983829049132980382904913298

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.

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
800-638-8663technical_services@bd.com

Regulatory Flags#

DUNS number
103318015
Device count
96
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10382904912533BD SurePath™ Collection Vial Kit 5004912534912532017-09-08
10382904905245ROVERS® CERVEX-BRUSH® 4905244905242016-09-24
10382904905269Rovers ® Combo-brush® 4905264905262016-09-24
00382904913083BD Totalys™ SlidePrep Consumables Kit4913084913082016-06-23
00382904913113BD PrepStain™ Consumables Kit4913114913112017-09-08
00382904913137BD PrepMate™ Consumables Kit4913134913132017-09-08
00382904913106BD Totalys™ MultiProcessor Consumables Kit4913104913102016-06-23
30382904913244BD SurePath™ Collection Vial Kit 254913244913242016-06-23
30382904913305BD Settling Chambers4913304913302015-05-05
00382904912475BD SurePath4912474912472017-09-08
00382904913069BD Density Reagent4913064913062017-09-08
00382904913885BD Totalys™ SlidePrep Slide Library Kit4913884913882016-06-23
30382904905119BD SurePath4905114905112015-07-23
30382904905171PrepStain® Syringing Pipettes 4905174905172015-05-05
30382904905201PrepStain® Settling Chambers4905204905202015-05-05
30382904905225BD SurePath4905224905222015-07-23
00382904901042BD PrepStain Slide Processor4901044901042015-07-22
00382904904104BD PrepStain Slide Processor4904104904102015-07-22
00382904905071BD SurePath4905074905072015-07-22
00382904905217BD PrepStain4905214905212015-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045513860ThinPrepHologic, Inc.MKQ2024-05-20
15420045514133ThinPrepHologic, Inc.MKQ2024-05-20
15420045514140ThinPrepHologic, Inc.MKQ2024-05-20
15420045514157ThinPrepHologic, Inc.MKQ2024-05-20
25420045514680ThinPrep Pap TestHologic, Inc.MKQ2021-09-29
15420045514683ThinPrep Pap TestHologic, Inc.MKQ2021-09-29
15420045514652ThinPrep® Pap TestHologic, Inc.MKQ2021-09-17
15420045513945ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
15420045513952ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
10382904913318BD Syringing PipettesBECTON, DICKINSON AND COMPANYMKQ2018-10-01
10382904914520BD SurePath™ Collection VialBECTON, DICKINSON AND COMPANYMKQ2018-08-23
30382904914524BD SurePath™ Collection VialBECTON, DICKINSON AND COMPANYMKQ2018-08-23
00382904914530BD Totalys™ MultiProcessor Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914547BD PrepStain™ Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914554BD PrepMate™ Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914561BD Totalys™ SlidePrep Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-03
10382904912533BD SurePath™ Collection Vial Kit 500TRIPATH IMAGING, INC.MKQ2017-09-08
10382904905276SurePath Preservative Fluid Collection VialBECTON, DICKINSON AND COMPANYMKQ2017-09-08
30382904912483BD SurePath™ PreCoat SlidesBECTON, DICKINSON AND COMPANYMKQ2017-09-08
30382904913312BD Syringing PipettesBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904911034BD PrepMate™ Automated AccessoryBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912475BD SurePathTRIPATH IMAGING, INC.MKQ2017-09-08
00382904912574BD PrepMate™ Automated AccessoryBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912666BD SurePath™ Manual Method KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912673BD PrepStain™ Slide Library KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
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
00382904913137BD PrepMate™ Consumables KitTRIPATH IMAGING, INC.MKQ2017-09-08