FDA.reportPublic FDA data

BD™ FocalPoint™ Slide Profiler Refurbished

Primary DI
00382904914905
Brand
BD™ FocalPoint™ Slide Profiler Refurbished
Company
BECTON, DICKINSON AND COMPANY
Model
491490
Catalog number
491490
Device description
Focal Point Digital Refurb 2
Published
2023-09-08
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
MNMREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904914905PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904914905003829049149053829049149050382904914905

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, manualAn electrically-powered manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature
Storage Environment Temperature18 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
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045515062ThinPrep Imaging SystemHologic, Inc.MNM2022-08-24
15420045513716Thinprep Imaging SystemHologic, Inc.MNM2020-06-24
00382904914646BD FocalPoint Slide ProfilerBECTON, DICKINSON AND COMPANYMNM2019-12-03
15420045512511ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
15420045512535ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
00382904910907BD FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2019-06-27
15420045508156ThinPrep Imaging SystemHologic, Inc.MNM2018-10-13
15420045508040ThinPrep Imaging SystemHologic, Inc.MNM2018-05-23
15420045508163Thinprep Imaging SystemHologic, Inc.MNM2017-10-13
00382904901899BD FocalPoint™ GS Review StationBECTON, DICKINSON AND COMPANYMNM2017-09-08
15420045507258ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
15420045507265ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
00382904910853BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910860BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910877BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
15420045504035ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504103ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504042ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504080ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504097ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045500891ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500907ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500914ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500921ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500938ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500945ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500976ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500983ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500990ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045501003ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02