BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- MiniDraw SST EUDAMEDBD MiniDraw™ Capillary Tube Adapter SST™ FDA UDI
- Generic Name
- Instrument/analyser test tube rack adaptor IVD FDA UDI
- Device Name
- BD MiniDraw™ Capillary Blood Collection Tubes EUDAMEDBD MiniDraw™ Capillary Blood Collection Tube Adapters EUDAMEDBD MiniDraw™ Capillary Tube Adapter SST™ FDA UDI
- Model / Reference
- 366620 EUDAMEDFDA UDI366604 EUDAMED
- Description
- BD MiniDraw™ Capillary Tube Adapter SST™ FDA UDI
Identifiers
- Catalog Number
- 366620 FDA UDI
- Primary DI / UDI-DI
- 50382903666206 EUDAMEDFDA UDI30382903666042 EUDAMED
- Basic UDI-DI
- 038290ISEGUFWUCW EUDAMED038290JFRZPBZZHA EUDAMED
- Unit of Use DI
- 00382903666041 EUDAMED00382903666201 EUDAMED
- 510(k) Number
- FDA Product Code
- JKA FDA 510(k)FDA UDI
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMEDW0501010280 CAPILLARY BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Instrument/analyser test tube rack adaptor IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass 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
Single Use
No
Implantable
No
Contains Latex
No
Human Tissues
No
Animal Tissues
Yes
Microbial Substances
No
Reagent
No
Self Testing
No
Near-Patient Testing
No
Professional Testing
Yes
Companion Diagnostics
No
Surgical Instrument
No
New Device
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
The BD MiniDraw Capillary Blood Collection System with BD MiniDraw SST Capillary Blood Collection Tube is a capillary blood collection device designed for the collection, separation, and processing of small blood samples. It is classified under the Clinical Chemistry category and intended for use in obtaining capillary blood from patients aged 18 years and older. The system includes a dedicated SST (Serum Separator Tube) for serum-based testing, ensuring sample integrity for laboratory analysis.
This system is supplied as a single-use, non-sterile device and is intended for use in clinical or point-of-care settings. It does not require MRI compatibility considerations. The device is authorised under FDA 510(k) clearance (K230391) and meets In Vitro Diagnostic Regulation (IVDR) requirements. Storage conditions are not specified in the data, but standard medical device handling practices should be followed.
Frequently asked questions
What age group is the BD MiniDraw Capillary Blood Collection System intended for, and why is this important for my lab or clinic?
The BD MiniDraw Capillary Blood Collection System is specifically designed for patients aged 18 years and older. This distinction is important because capillary blood collection techniques and tube sizes may vary by age group, and the system is optimized for adult patients. Using it on younger patients could compromise sample integrity or collection efficiency, so always verify patient age before use.
Is the BD MiniDraw Capillary Blood Collection System sterile, and how does this affect its use in clinical settings?
The BD MiniDraw Capillary Blood Collection System is non-sterile as supplied. This means it should be handled in a manner consistent with standard medical device practices to prevent contamination. While it is intended for clinical or point-of-care settings, users must follow proper aseptic techniques—such as cleaning the collection site with an antiseptic—before use to ensure sample safety and reliability.
How is the BD MiniDraw Capillary Blood Collection System supplied, and what does this mean for inventory management?
The system is supplied as a single-use device, meaning each unit is intended for one collection procedure only. This design reduces cross-contamination risks and ensures sample integrity. For inventory management, this means ordering in bulk while accounting for usage rates, as unused units cannot be reprocessed or reused. Always check expiration dates and store according to standard medical device practices.
What type of blood sample does the BD MiniDraw SST Capillary Blood Collection Tube collect, and why is this relevant for laboratory testing?
The BD MiniDraw SST Capillary Blood Collection Tube is designed for serum-based testing, meaning it separates serum from whole blood after collection. This is relevant for labs because serum is commonly used for chemistry panels, immunology tests, and other diagnostic assays where clotting factors must be excluded. The SST tube’s design ensures sample stability and clarity for accurate laboratory analysis.
What regulatory pathways does the BD MiniDraw Capillary Blood Collection System follow, and how does this impact its use in different markets?
The device is authorized under FDA 510(k) clearance (K230391) and complies with the In Vitro Diagnostic Regulation (IVDR). This means it is legally marketable in the U.S. and EU (or other IVDR-adhering regions) without additional country-specific approvals. For buyers, this simplifies procurement in regulated markets, though always verify local compliance requirements before use, as some regions may have additional labeling or handling mandates.
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™ SST ..., Becton Dickinson – Wikipedia, PDF K230391 - Food and Drug Administration, Evaluation of a Novel Capillary Blood Collection System for Blood ...
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K230391 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (4)
- FDA 510(k) K230391 24 fields · synced Sep 18, 2026
- FDA UDI b9de9f4f-a44c-4bee-949a-62b9fe263522 36 fields · synced May 30, 2026
- EUDAMED b5318278-31d9-4bb8-9790-81ea6a5d79de 61 fields · synced Jul 8, 2026
- EUDAMED df9bd1c0-bdb0-4b7f-bab5-f3503e7193cb 61 fields · synced Aug 1, 2026