FDA.reportPublic FDA data

BD MiniDraw Finger Sizing Tool

Primary DI
00382903666171
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
OTC
false
Sterile
false
Single use
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
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
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
059454260
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
00850058457048BD MiniDraw Capillary Tube Adapter H&H366619-10366619-102025-12-09
00850058457055BD MiniDraw Finger Sizing Tool366617-100366617-1002025-12-09
00850058457031BD MiniDraw Capillary Tube Adapter SST366620-10366620-102025-12-09
00850058457017Babson Sample Preparation DeviceBabson Sample Preparation DeviceSE-9-020012024-05-13
00850058457000Babson Hand WarmerBabson Hand WarmerWI-1-A32800200012024-01-12

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
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
50382903666190BD MiniDraw™ Capillary Tube Adapter H&HBECTON, 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