FDA.reportPublic FDA data

BD FACSuite

Primary DI
00382906630032
Brand
BD FACSuite
Company
Becton, Dickinson And Company
Model
663003
Catalog number
663003
Device description
BD FACSuite™ Clinical Flow Cytometry Software v1.3
Published
2018-01-10
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
OYEFlow cytometric reagents and accessories.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OYEFlow Cytometric Reagents And Accessories.Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170974000BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company2017-07-03OYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906630032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906630032003829066300323829066300320382906630032

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser operation system software IVDMainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
119218200
Device count
1
Lot or batch
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
15099590754013DxFLEXBeckman Coulter, Inc.OYE2025-09-02
00382906657329BD FACSuiteBecton, Dickinson And CompanyOYE2024-01-09
00382906642363FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642370FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642356FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906635181FACSLyricBecton, Dickinson And CompanyOYE2022-10-12
00382906654212FACSDivaBecton, Dickinson And CompanyOYE2022-10-12
00382906631282BD FACSDuetBecton, Dickinson And CompanyOYE2022-08-23
00382906650061BD FACSuiteBecton, Dickinson And CompanyOYE2022-07-15
00382906642868FACSDivaBECTON, DICKINSON AND COMPANYOYE2020-05-05
00382906643452BD FACSDivaBecton, Dickinson And CompanyOYE2020-05-05
00382906641106FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641120FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641175BD FACSDivaBecton, Dickinson And CompanyOYE2020-04-08
00382906641182BD FACSDivaBecton, Dickinson And CompanyOYE2020-04-08
00382906641243FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641267FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906629654BD MultitestBecton, Dickinson And CompanyOYE2019-01-14
00382906630056BD FACSuiteBecton, Dickinson And CompanyOYE2018-01-10
00382906630070BD FACSuiteBecton, Dickinson And CompanyOYE2018-01-10
00382906629678BD MultitestBecton, Dickinson And CompanyOYE2017-12-12
00382906628794FACSBecton, Dickinson And CompanyOYE2017-10-24
00382906628756BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628763BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628770BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628787BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906629616N/ABecton, Dickinson And CompanyOYE2017-09-21
00382906623867FACSViaBECTON, DICKINSON AND COMPANYOYE2017-08-31
00382906624130N/ABecton, Dickinson And CompanyOYE2017-08-30
00382906624147N/ABecton, Dickinson And CompanyOYE2017-08-30