FDA.reportPublic FDA data

BD FocalPoint™ GS Review Station

Primary DI
00382904901899
Brand
BD FocalPoint™ GS Review Station
Company
BECTON, DICKINSON AND COMPANY
Model
490189
Catalog number
490189
Device description
BD FocalPoint™ GS Review Station Computer
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
MNMReader, Cervical Cytology Slide, Automated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950009008

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950009008AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMBd Diagnostics1995-09-29MNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904901899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904901899003829049018993829049018990382904901899

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, manualA mains electricity (AC-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 and operates with technician involvement in most procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height33.2Centimeter
Length59.2Centimeter
Width55Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius60 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
50382905167015BD Intelliport5167015167012020-09-30
00382905167508BD Intelliport5167505167502020-09-30
00382905168031BD Intelliport System5168035168032024-06-07
00382905168000BD Intelliport System5168005168002024-06-07
00382905167041BD Intelliport5167045167042020-09-30
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904914905BD™ FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2023-09-08
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
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