FDA.reportPublic FDA data

BD MiniDraw™ Capillary Tube Adapter H&H

Primary DI
50382903666190
Brand
BD MiniDraw™ Capillary Tube Adapter H&H
Company
BECTON, DICKINSON AND COMPANY
Model
366619
Catalog number
366619
Device description
BD MiniDraw™ Capillary Tube Adapter H&H
Published
2024-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GIMTubes, vacuum sample, with anticoagulant

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230493000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230493000BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection TubeBecton, Dickinson and Company2023-11-27GIM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903666190PrimaryGS10
00382903666195Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290366619050382903666190
00382903666195003829036661953829036661950382903666195

GMDN Terms#

Term, Definition table
TermDefinition
Instrument/analyser test tube rack adaptor IVDA device intended to be used on-board an in vitro diagnostic laboratory instrument or analyser to allow test tubes or vials of a nonstandard size to be placed onto an instrument/analyser test tube rack. It is typically made of metal or plastic. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
001292192
Device count
500
DM exempt
true
Lot or batch
true
Manufacturing date on label
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
20192253050988MonojectCardinal Health 200, LLCGIM2026-05-05
00850058457048BD MiniDraw Capillary Tube Adapter H&HBabson Diagnostics, Inc.GIM2025-12-09
00850058457055BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
00382903666171BD MiniDraw Finger Sizing ToolBabson Diagnostics, Inc.GIM2025-12-09
10197106953433CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50197106953431CARDINAL HEALTHCardinal Health 200, LLCGIM2025-03-28
50192253051214CovidienCardinal Health 200, LLCGIM2025-01-14
10192253051216CovidienCardinal Health 200, LLCGIM2025-01-14
20192253051183MonojectCardinal Health 200, LLCGIM2024-10-08
50192253051184MonojectCardinal Health 200, LLCGIM2024-10-08
50382903666039BD MiniDraw™ H&H Capillary Blood Collection TubeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666138BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666145BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666152BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666169BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
50382903666176BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, SmallBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, MediumBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-LargeBECTON, DICKINSON AND COMPANYGIM2024-06-06
30382903666172BD MiniDraw™ Finger Sizing ToolBECTON, DICKINSON AND COMPANYGIM2024-06-06
20192253050926MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050940MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050971MonojectCardinal Health 200, LLCGIM2024-02-28
20192253050995MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051008MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051015MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051022MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051039MonojectCardinal Health 200, LLCGIM2024-02-28
20192253051053MonojectCardinal Health 200, LLCGIM2024-02-28