FDA.reportPublic FDA data

BD Kiestra™ ErgonomicA Connection Panel

Primary DI
00382904960216
Brand
BD Kiestra™ ErgonomicA Connection Panel
Company
BD Kiestra B.V.
Model
496021
Catalog number
496021
Device description
BD Kiestra™ ErgonomicA Connection Panel
Published
2023-09-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQPCalculator/data processing module, for clinical use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQPCalculator/Data Processing Module, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904960216PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904960216003829049602163829049602160382904960216

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory container/microscope slide robotic transfer system IVDAn assembly of electrically-powered robotic devices, a stand-alone device, or a belt conveyor intended to be used for the automated or semi-automated transfer of assay containers (e.g., test tubes, microplates), microscope slides/slide carriers, or racks between processing stations. The system may interface with individual instruments/analysers and other equipment, transporting assay containers between stations which may include specimen pipetting, reagent dispensing, incubation, microplate washing, agitation, barcode reading and/or optical reading.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
417876166
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904449087BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application4449084449082025-12-17
00382904472023BD Kiestra™ InoqulA+™4472024472022018-05-25
00382904472061BD Kiestra™ ReadA™ Compact4472064472062018-05-25
00382904472139BD Kiestra™ InoqulA+™ TLA4472134472132018-05-25
00382904469481BD Kiestra™ ReadA4469484469482023-09-14
00382904460921BD Kiestra™ T-junction4460924460922023-10-19
00382904469733BD Kiestra™ InoqulA4469734469732025-02-18
00382904460969BD Kiestra™ Regular Base4460964460962023-10-23
00382904460976BD Kiestra™ Main Base4460974460972023-10-20
00382904460938BD Kiestra™ ErgonomicA Connector R4460934460932023-10-19
00382904460945BD Kiestra™ ErgonomicA Connector L4460944460942023-10-19
00382904460983BD Kiestra™ Corner4460984460982023-10-19
00382904469443BD Kiestra™ U-Turn4469444469442023-10-20
00382904469467BD Kiestra™ Straight4469464469462023-10-20
00382904469412BD Kiestra™ Frame4469414469412023-10-19
00382904469429BD Kiestra™ Main Base Light4469424469422023-10-19
00382904469436BD Kiestra™ Destacker4469434469432023-10-19
00382904469450BD Kiestra™ Standard Connector4469454469452023-10-19
00382904469474BD Kiestra™ Stacker4469474469472023-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810142374064SoftBiobankSCC SOFT COMPUTERJQP2026-05-05
00810142373975SoftBiochemistrySCC SOFT COMPUTERJQP2026-04-16
00810142373982SoftCytogeneticsSCC SOFT COMPUTERJQP2026-04-16
00810142373999SoftPathDxSCC SOFT COMPUTERJQP2026-04-16
00810142374002SoftFlowCytometrySCC SOFT COMPUTERJQP2026-04-16
00810142374019SoftHLASCC SOFT COMPUTERJQP2026-04-16
00810142374026SoftMolecularSCC SOFT COMPUTERJQP2026-04-16
00810142374033SoftGenomicsSCC SOFT COMPUTERJQP2026-04-16
00810142374040SoftTrackSCC SOFT COMPUTERJQP2026-04-16
00810142373586SoftTotalQCSCC SOFT COMPUTERJQP2026-03-28
00810142373715SoftBiochemistrySCC SOFT COMPUTERJQP2026-03-12
00810142373722SoftCytogeneticsSCC SOFT COMPUTERJQP2026-03-12
00810142373739SoftPathDxSCC SOFT COMPUTERJQP2026-03-12
00810142373746SoftFlowCytometrySCC SOFT COMPUTERJQP2026-03-12
00810142373753SoftHLASCC SOFT COMPUTERJQP2026-03-12
00810142373760SoftMolecularSCC SOFT COMPUTERJQP2026-03-12
00810142373777SoftGenomicsSCC SOFT COMPUTERJQP2026-03-12
00810142373784SoftTrackSCC SOFT COMPUTERJQP2026-03-12
00810142373340SoftTotalQCSCC SOFT COMPUTERJQP2026-03-11
00810142373593SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-21
00810142373609SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-21
00810142373616SoftPathDxSCC SOFT COMPUTERJQP2026-02-21
00810142373623SoftFlowCytometrySCC SOFT COMPUTERJQP2026-02-21
00810142373630SoftHLASCC SOFT COMPUTERJQP2026-02-21
00810142373647SoftMolecularSCC SOFT COMPUTERJQP2026-02-21
00810142373654SoftGenomicsSCC SOFT COMPUTERJQP2026-02-21
00810142373661SoftTrackSCC SOFT COMPUTERJQP2026-02-21
00810142373500SoftBiochemistrySCC SOFT COMPUTERJQP2026-02-04
00810142373517SoftCytogeneticsSCC SOFT COMPUTERJQP2026-02-04
00810142373524SoftPathDxSCC SOFT COMPUTERJQP2026-02-04