BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Vacutainer Barricor EUDAMED
- Device Name
- BD Vacutainer® Barricor™ LH Plasma Blood Collection Tube EUDAMED
- Model / Reference
- 360063 EUDAMED365050 EUDAMED365081 EUDAMED365054 EUDAMED365056 EUDAMED365055 EUDAMED365066 EUDAMED365049 EUDAMED365057 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00382903600632 EUDAMED30382903650508 EUDAMED30382903650812 EUDAMED30382903650546 EUDAMED30382903650560 EUDAMED30382903650553 EUDAMED00382903650668 EUDAMED30382903650492 EUDAMED30382903650577 EUDAMED
- Basic UDI-DI
- 038290OKYSFZWGPF EUDAMED
- Unit of Use DI
- 00382903650507 EUDAMED00382903650811 EUDAMED00382903650545 EUDAMED00382903650569 EUDAMED00382903650552 EUDAMED00382903650491 EUDAMED00382903650576 EUDAMED
- 510(k) Number
- K160657 FDA 510(k)
- FDA Product Code
- JKA FDA 510(k)
- EMDN Code
- W050101010201 BLOOD COLLECTION, TUBES WITH ADDITIVES OR SERUM SEPARATOR EUDAMED
Classification
- Device Class
- Class A EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1675 FDA 510(k)
- Regulation Number
- 862.1675 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
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
This device is a Plasma Blood Collection Tube (Nomenclature: JKA) designed for the collection, separation, and processing of venous blood samples. It incorporates a mechanical separator to facilitate plasma separation and is intended for in vitro diagnostic use, including chemistry determinations, therapeutic drug monitoring, and zinc testing in plasma.
The BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube is used in clinical settings for blood sample collection via venipuncture. It is supplied as a single-use, sterile, evacuated tube with lithium heparin as the anticoagulant. Centrifugation at a minimum relative centrifugal force (RCF) of 1800 for 10 minutes in a swinging bucket centrifuge is required for plasma separation. Authorised under FDA 510(k) clearance (K160657) and IVDR compliance.
Frequently asked questions
What types of blood tests can this tube be used for according to its intended purpose?
This BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube is specifically designed for in vitro diagnostic use, including chemistry determinations, therapeutic drug monitoring, and zinc testing in plasma. The lithium heparin anticoagulant ensures plasma remains stable for these analyses after centrifugation.
How is this tube different from standard blood collection tubes in terms of its function?
Unlike standard tubes, this BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube includes a mechanical separator to physically isolate plasma from cells after centrifugation, simplifying sample processing for plasma-based diagnostics. It also uses lithium heparin as the anticoagulant, which is ideal for tests requiring plasma rather than serum.
Is this tube reusable, or is it meant for single-use only?
This tube is explicitly designed for single-use only. It is supplied sterile and evacuated for one-time blood collection via venipuncture, ensuring patient safety and preventing cross-contamination between samples.
What centrifugation settings are required to properly separate plasma from whole blood in this tube?
The manufacturer specifies a minimum relative centrifugal force (RCF) of 1800 for 10 minutes in a swinging bucket centrifuge to effectively separate plasma from whole blood. This ensures accurate plasma collection for diagnostic testing.
How is this tube authorized for use in the United States and Europe?
In the U.S., this tube holds FDA 510(k) clearance (K160657) under the Traditional pathway, deemed substantially equivalent to a predicate device. It also complies with the In Vitro Diagnostic Regulation (IVDR) in Europe, meeting regulatory standards for plasma-based diagnostic testing.
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 Vacutainer® Heparin Tubes - 367884 | BD, Becton Dickinson – Wikipedia, BD Vacutainer Barricor Lithium Heparin Plasma Blood Collection Tube ..., BD Vacutaine® Barricor™ Plasma Blood Collection Tubes, Li Heparin, Lime ...
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 | K160657 | Class II | Active |
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Manufacturer
- Manufacturer
- Becton, Dickinson and Company
Sources (10)
- FDA 510(k) K160657 24 fields · synced Sep 18, 2026
- EUDAMED 084b4599-0a67-4171-80ed-8c4617695916 61 fields · synced Jul 8, 2026
- EUDAMED 77834db6-a9b2-4b8a-9ea1-0ff075deeb1f 61 fields · synced Jul 8, 2026
- EUDAMED 4cd49f6a-e84b-4d2c-a49b-b5ae12e55045 61 fields · synced Jul 9, 2026
- EUDAMED 085067a9-41c4-4194-9dac-3b634daec196 61 fields · synced Jul 9, 2026
- EUDAMED ce99f937-7e34-432a-b538-e372f17df607 61 fields · synced Jul 10, 2026
- EUDAMED 7596f35c-4313-4126-9abe-50e1787d21f5 61 fields · synced Jul 11, 2026
- EUDAMED 578b59bb-2185-4ace-9a91-cf928e689a7e 61 fields · synced Jul 13, 2026
- EUDAMED df49d274-4949-4e96-84c5-ee1ebb3a1f40 61 fields · synced Jul 14, 2026
- EUDAMED 8d274f82-9e81-4852-9884-b05c2035ca10 61 fields · synced Jul 26, 2026