FDA.reportPublic FDA data

BD PrepMate™ Automated Accessory

Primary DI
00382904911034
Brand
BD PrepMate™ Automated Accessory
Company
BECTON, DICKINSON AND COMPANY
Model
491103
Catalog number
491103
Device description
BD PrepMate™ Automated Accessory (100-240V)
Published
2017-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
P970018028

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970018028BD PREPSTAIN SYSTEMBd Diagnostic Systems1999-06-17MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904911034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904911034003829049110343829049110340382904911034

GMDN Terms#

Term, Definition table
TermDefinition
Tissue processor IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth23Inch
Height21Inch
Height22Inch
Width12.5Inch
Width14Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

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
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
00382904913328BD Density Reagent (480 ml)BECTON, DICKINSON AND COMPANYMKQ2017-09-08