BD Microtainer® Contact-Activated Lancets - BD Microtainer® Quikheel™ Lancets
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Microtainer EUDAMED
- Device Name
- BD Microtainer® Blood Collection Tubes EUDAMEDBD Microtainer® Blood Collection Tube Extender EUDAMED
- Model / Reference
- 365964 EUDAMED363707 EUDAMED368933 EUDAMED365993 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 30382903659648 EUDAMED00382903637072 EUDAMED30382903689331 EUDAMED30382903659938 EUDAMED
- Basic UDI-DI
- 038290NWQEDLUVKA EUDAMED038290PGYHYFTAJH EUDAMED
- Unit of Use DI
- 00382903659647 EUDAMED00382903689330 EUDAMED00382903659937 EUDAMED
- 510(k) Number
- K223243 FDA 510(k)
- FDA Product Code
- FMK FDA 510(k)
- EMDN Code
- W0501010203 BLOOD COLLECTION, CAPILLARY TUBES EUDAMEDW0501010280 CAPILLARY BLOOD COLLECTION DEVICES - ACCESSORIES EUDAMED
- Models / Variants
- BD Microtainer® Quikheel™ Lancets FDA 510(k)EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4850 FDA 510(k)
- Regulation Number
- 878.4850 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
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
The BD Microtainer Contact-Activated Lancets and BD Microtainer Quikheel Lancets are single-use, disposable lancets designed for blood collection. These devices are intended for percutaneous skin puncture to obtain capillary blood samples, commonly used in point-of-care testing and laboratory diagnostics.
These lancets are supplied sterile and intended for single-use only, ensuring patient safety and minimizing infection risk. They are classified under product code FMK and have received FDA 510(k) clearance, IVDR, and MDR authorizations. The devices are packaged individually for convenience and must be stored in a clean, dry environment prior to use.
Frequently asked questions
Are these lancets reusable or designed for single-use, and why does that matter for patient safety?
These lancets are intended for single-use only, as explicitly stated in the device description. This design ensures patient safety by minimizing infection risk, as reuse could introduce contamination from previous use. Single-use also reduces the risk of cross-contamination between patients, aligning with best practices for sterile medical devices in blood collection.
How should I store these lancets before use, and what happens if they’re exposed to moisture?
The packaging instructions specify storage in a clean, dry environment prior to use. Exposure to moisture could compromise sterility, as moisture may alter the integrity of the packaging or the lancet itself. Ensuring a dry storage area helps maintain the device’s sterile condition, which is critical for reliable blood collection and infection prevention.
What types of blood collection procedures are these lancets most commonly used for?
These lancets are designed for percutaneous skin puncture to obtain capillary blood samples, which are commonly used in point-of-care testing (e.g., glucose monitoring, rapid infectious disease testing) and laboratory diagnostics. Their compact, single-use design makes them ideal for quick, low-volume blood draws in settings like clinics, hospitals, or home healthcare.
Are these lancets available in multiple sizes or models, and if so, how would I know which one to select?
The provided data does not specify individual sizes or models beyond the two product lines (Contact-Activated and Quikheel). Selection would typically depend on clinical needs—such as depth of puncture required or patient comfort—but the manufacturer’s documentation or sales team would provide guidance on compatibility with specific collection tubes or devices. Always verify compatibility with your intended use case.
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: Becton Dickinson – Wikipedia, BD (company) - Wikipedia
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
IVDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| EUDAMED | European Union | IVDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K223243 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (5)
- FDA 510(k) K223243 24 fields · synced Oct 6, 2026
- EUDAMED 7644a72b-9259-460a-bbc7-f2506de8783a 61 fields · synced Jul 9, 2026
- EUDAMED 8fed84e9-8cb9-456b-a02a-f8365f424162 61 fields · synced Jul 12, 2026
- EUDAMED f4c80b4a-2453-45c6-af2e-470910087274 61 fields · synced Jul 16, 2026
- EUDAMED 24aa8746-2ce9-459b-8939-bc89d3774031 61 fields · synced Jul 27, 2026