BD Preset and BD A-Line Arterial Blood Collection Syringes
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Preset EUDAMEDBD Preset™ Arterial Blood Collection Syringe FDA UDI
- Generic Name
- Blood gas syringe IVD, lithium heparin FDA UDI
- Device Name
- BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes EUDAMEDSYR ABG PRESET 3(1.6) LL CE FDA UDI
- Model / Reference
- 364316 EUDAMEDFDA UDI
- Description
- SYR ABG PRESET 3(1.6) LL CE FDA UDI
Identifiers
- Catalog Number
- 364316 FDA UDI
- Primary DI / UDI-DI
- 50382903643160 EUDAMEDFDA UDI
- Basic UDI-DI
- 038290UJSKOQNYN5 EUDAMED
- Unit of Use DI
- 00382903643165 EUDAMED
- FDA Product Code
- JKA FDA 510(k)FDA UDI
- EMDN Code
- W0501010103 BLOOD GAS SAMPLES COLLECTION, SYRINGES WITHOUT NEEDLE EUDAMED
- GMDN Term
- Blood gas syringe IVD, lithium heparin 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
Yes
Single Use
Yes
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
Yes
Manufacturing Date
No
The BD Preset and BD A-Line Arterial Blood Collection Syringes are sterile, single-use in vitro diagnostic devices designed for arterial blood collection. These syringes facilitate the precise withdrawal of whole blood specimens for laboratory analysis, including measurements of pH, blood gases, electrolytes, ionized calcium, metabolites, and co-oximetry.
These devices are intended for use in clinical chemistry settings and are supplied as single-use, sterile products. They are classified under the IVDR and have received FDA 510(k) clearance as substantially equivalent, with a special review designation. The syringes are packaged for immediate clinical use and comply with regulatory standards for in vitro diagnostics.
Frequently asked questions
What types of blood tests can these syringes be used for when collecting arterial blood samples?
These syringes are specifically designed for collecting arterial blood samples intended for laboratory analysis, including tests like pH measurement, blood gases, electrolytes, ionized calcium, metabolites, and co-oximetry. Their precision and sterile design ensure reliable specimen integrity for these clinical chemistry applications.
Are these syringes reusable or meant for single-use only, and why does that matter?
The BD Preset and BD A-Line Arterial Blood Collection Syringes are explicitly labeled as sterile, single-use devices. This matters because single-use syringes eliminate cross-contamination risks, reduce infection hazards, and ensure consistent performance for accurate diagnostic results—critical for sensitive arterial blood tests.
How are these syringes packaged, and do they require any special handling before use?
They are supplied as pre-sterilized, ready-to-use syringes in packaging designed for immediate clinical application. No additional sterilization or preparation is needed; simply remove from the package under sterile conditions before use, as they’re intended for direct arterial blood collection without further processing.
What distinguishes the BD Preset and BD A-Line models from each other in terms of design or function?
While both are arterial blood collection syringes, the BD Preset and BD A-Line models may differ in specific design features (e.g., needle gauge, plunger mechanism, or connector type) to optimize workflows for different clinical settings. The manufacturer’s documentation would detail these distinctions, but both share the same core purpose: precise, sterile arterial blood withdrawal for lab analysis.
How should these syringes be stored, and what are the implications of improper storage?
They should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Improper storage could compromise sterility or integrity, risking contamination or device failure—potentially leading to inaccurate blood test results or procedural delays.
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® Critical Care Blood Collection Syringes | BD, BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes (K260128 ..., Becton Dickinson – Wikipedia, BD Preset Syringe Usage Guide
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 | K260128 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (3)
- FDA 510(k) K260128 24 fields · synced Sep 18, 2026
- FDA UDI c5f235af-fec2-45de-9e0c-7e9302656c0f 36 fields · synced May 30, 2026
- EUDAMED dd3968b5-5df5-4a21-928c-dbd589f86800 61 fields · synced Aug 1, 2026