FDA.reportPublic FDA data

BD MiniDraw™ Finger Sleeve, Small

Primary DI
30382903666134
Brand
BD MiniDraw™ Finger Sleeve, Small
Company
BECTON, DICKINSON AND COMPANY
Model
366613
Catalog number
366613
Device description
BD MiniDraw™ Finger Sleeve, Small
Published
2024-06-06
Public version status
Update
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
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
K252378000

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
K252378000BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection TubeBecton, Dickinson and Company2026-04-10JKA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50382903666138PackageGS136In Commercial Distribution
30382903666134PrimaryGS10
00382903666133Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5038290366613850382903666138
3038290366613430382903666134
00382903666133003829036661333829036661330382903666133

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection funnelA device intended to be used to channel capillary blood from the lancing site on a finger into a blood collection tube. It is a wearable splint-like device placed over the finger with a connector on the distal end, onto which the blood collection tube is attached. The device can also be gently squeezed to massage the finger and encourage blood flow; it can be used by healthcare professionals in clinical settings and by laypersons in the home. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Regulatory Flags#

DUNS number
001292192
Device count
50
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
false
Expiration date on label
true
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
00382903935314Nexiva3935313935312026-07-30
00382903935321Nexiva3935323935322026-07-30
00382903935338Nexiva3935333935332026-07-30
00382903935345Nexiva3935343935342026-07-30
00382903935352Nexiva3935353935352026-07-30
00382903935369Nexiva3935363935362026-07-30
00382903935376Nexiva3935373935372026-07-30
00382903935383Nexiva3935383935382026-07-30
00885403523000FOGARTY SOFTJAWCSOFT6CSOFT62026-07-30
00885403523161FOGARTY HYDRAJAWHYDRA33HYDRA332026-07-30
00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
00885403523277FOGARTY SOFTJAWSOFT86SOFT862026-07-30
00885403529637Acumen IQAIQCAAIQCA2026-07-29
00885403529668Acumen IQAIQCSAIQCS2026-07-29
00885403529774ClearSight JrCSCJR1CSCJR12026-07-29
00885403529781ClearSightCSCLCSCL2026-07-29
00885403529798ClearSightCSCMCSCM2026-07-29
00885403529811ClearSightCSCSCSCS2026-07-29
00885403529828VitaWaveVWCAVWCA2026-07-29
00885403522393Swan-Ganz834F75834F752026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344216123MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-24
30382903679929BD Vacutainer® SST™ Blood Collection TubeBECTON, DICKINSON AND COMPANYJKA2026-07-20
10197344112722MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216116MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216130MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216147MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216154MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216161MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216178MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
10197344216185MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-07-17
00850048720343C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720466C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720558C-QuestLifeOutcomes LLCJKA2026-07-14
00850048720237C-QuestLifeOutcomes LLCJKA2026-07-09
50192253051153CARDINAL HEALTHCardinal Health 200, LLCJKA2026-06-25
00199536930506BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
00199536930513BluelineTransparent Supply Solutions Ltd.JKA2026-06-05
08887629000008BUHNSP TECH PTE LTDJKA2026-05-29
08887629000053BUCANSP TECH PTE LTDJKA2026-05-29
08887629000060BTANSP TECH PTE LTDJKA2026-05-29
08586015044786CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044793CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044809CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044816CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27