FDA.reportPublic FDA data

BD MiniDraw Capillary Tube Adapter SST

Primary DI
00850058457031
Brand
BD MiniDraw Capillary Tube Adapter SST
Company
Babson Diagnostics, Inc.
Model
366620-10
Catalog number
366620-10
Device description
BD MiniDraw Capillary Tube Adapter SST
Published
2025-12-09
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
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230391000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230391000BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company2023-12-01JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850058457031PrimaryGS10
00382903666201Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058457031008500584570318500584570310850058457031
00382903666201003829036662013829036662010382903666201

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059454260
Device count
10
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058457048BD MiniDraw Capillary Tube Adapter H&H366619-10366619-102025-12-09
00850058457055BD MiniDraw Finger Sizing Tool366617-100366617-1002025-12-09
00382903666171BD MiniDraw Finger Sizing Tool366617-100366617-1002025-12-09
00850058457017Babson Sample Preparation DeviceBabson Sample Preparation DeviceSE-9-020012024-05-13
00850058457000Babson Hand WarmerBabson Hand WarmerWI-1-A32800200012024-01-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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