FDA.reportPublic FDA data

BD MiniDraw Finger Sizing Tool

Primary DI
00850058457055
Brand
BD MiniDraw Finger Sizing Tool
Company
Babson Diagnostics, Inc.
Model
366617-100
Catalog number
366617-100
Device description
BD MiniDraw Finger Sizing Tool
Published
2025-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GIMTubes, Vacuum Sample, With Anticoagulant
JKATubes, Vials, Systems, Serum Separators, Blood Collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIMTubes, Vacuum Sample, With AnticoagulantClinical Chemistry2
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230391000
K230493000

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
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
00850058457055PrimaryGS10
00382903666171Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850058457055008500584570558500584570550850058457055
00382903666171003829036661713829036661710382903666171

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection finger diameter sizer IVDA device intended to be used to measure the diameter of a finger to aid in the selection of an appropriately-sized capillary blood collection finger squeezing sleeve. It is typically in the form of a paper/plastic sheet with holes of graduated sizes. This is a single-use device.

Regulatory Flags#

DUNS number
059454260
Device count
100
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
00850058457031BD MiniDraw Capillary Tube Adapter SST366620-10366620-102025-12-09
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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