← Back to catalogue

BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K230493Ref 366616Ref 366618Ref 366615Ref 366617Ref 366621Ref 366613Ref 366614

by Becton, Dickinson and Company

Identity

Trade Name
MiniDraw EUDAMED
BD MiniDraw™ Cap Removal Tool FDA UDI
Generic Name
Capillary blood collection tube opener IVD FDA UDI
Device Name
BD MiniDraw™ Cap Removal Tool EUDAMEDFDA UDI
BD MiniDraw™ Finger Sleeves EUDAMED
BD MiniDraw™ Finger Sizing Tool EUDAMED
BD MiniDraw™ Capillary Blood Collection Tube Adapters EUDAMED
Model / Reference
366618 EUDAMEDFDA UDI
366616 EUDAMED
366615 EUDAMED
366617 EUDAMED
366621 EUDAMED
366613 EUDAMED
366614 EUDAMED
Description
BD MiniDraw™ Cap Removal Tool FDA UDI

Identifiers

Catalog Number
366618 FDA UDI
Primary DI / UDI-DI
00382903666188 EUDAMEDFDA UDI
30382903666165 EUDAMED
30382903666158 EUDAMED
30382903666172 EUDAMED
50382903666213 EUDAMED
30382903666134 EUDAMED
30382903666141 EUDAMED
Basic UDI-DI
038290ISKUNRBOJ6 EUDAMED
038290IVDPIOARDQ EUDAMED
038290IUBXEAPYDW EUDAMED
038290JFRZPBZZHA EUDAMED
Unit of Use DI
00382903666164 EUDAMED
00382903666157 EUDAMED
00382903666171 EUDAMED
00382903666218 EUDAMED
00382903666133 EUDAMED
00382903666140 EUDAMED
Direct Marketing DI
00382903666188 EUDAMED
510(k) Number
K230493 FDA 510(k)FDA UDI
K230391 FDA UDI
FDA Product Code
GIM FDA 510(k)FDA UDI
JKA FDA UDI
EMDN Code
W0501010280 CAPILLARY BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
GMDN Term
Capillary blood collection tube opener IVD FDA UDI

Classification

Device Class
Class A EUDAMED
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 862.1675 FDA 510(k)
Regulation Number
862.1675 FDA 510(k)FDA UDI
Market of Registration
Belgium EUDAMED
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMEDEUDAMED

Microbial Substances

No

EUDAMED

Reagent

No

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube is a Tubes, Vacuum Sample, With Anticoagulant designed for collecting a small whole blood specimen from a fingerstick. It delivers an anticoagulated sample for subsequent measurement of hemoglobin and hematocrit in clinical chemistry applications.

This system is intended for single-use in point-of-care or clinical laboratory settings, where sterile collection and accurate hematological analysis are required. Supplied as a sterile, disposable device, it adheres to FDA 510(k) clearance (K230493) and IVDR compliance, with no MRI safety restrictions. The system includes pre-filled tubes with anticoagulant and is regulated under FDA regulation 862.1675.

Frequently asked questions

What is the BD MiniDraw Capillary Blood Collection System used for?

The BD MiniDraw Capillary Blood Collection System is designed for collecting small whole blood specimens from a fingerstick. It provides an anticoagulated sample specifically for measuring hemoglobin and hematocrit in clinical chemistry applications.

Is the BD MiniDraw system reusable or single-use?

The BD MiniDraw system is intended for single-use only. It is supplied as a sterile, disposable device designed for point-of-care or clinical laboratory settings where sterile collection is required.

What regulatory approvals does the BD MiniDraw system have?

The BD MiniDraw system has FDA 510(k) clearance (K230493) and IVDR compliance. It is regulated under FDA regulation 862.1675 and has no MRI safety restrictions.

How is the BD MiniDraw system supplied?

The system is supplied as a sterile, disposable device that includes pre-filled tubes with anticoagulant. It is designed for single-use in point-of-care or clinical laboratory settings.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H ..., Becton Dickinson – Wikipedia, BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H ..., BD Receives FDA 510(k) Clearance for Potentially Transformative ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

IVDR

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Becton, Dickinson and Company

Sources (9)

  • FDA 510(k) K230493 24 fields · synced Sep 18, 2026
  • FDA UDI ee844ad9-6a44-4226-8bff-96824fae7eea 35 fields · synced May 30, 2026
  • EUDAMED a35dabf6-bba0-4498-ac19-2a2a69d5567a 61 fields · synced Jul 9, 2026
  • EUDAMED 00d80777-ec67-4aa7-b07f-46729208907f 61 fields · synced Jul 9, 2026
  • EUDAMED c39f0548-123c-44d2-b791-e5fbe3736521 61 fields · synced Jul 10, 2026
  • EUDAMED 6f60f3b7-c966-457b-b672-5d352c583d50 61 fields · synced Jul 11, 2026
  • EUDAMED 4aa69e57-9750-45b1-8dd6-4f8f29512067 61 fields · synced Jul 13, 2026
  • EUDAMED 2fe7df94-23d6-4c4f-ba4e-01540f4315c4 61 fields · synced Jul 29, 2026
  • EUDAMED dd8d0fa5-0b0b-4083-b3fe-dd8366725675 61 fields · synced Jul 30, 2026