Sterile High-pressure Angiographic Syringes for Single-use 200/200 mL HS-BCD200
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMEDSinton Medical Products FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMED2-200ml Syringes 2-fill straws 1-72" Y Coiled Tubing with Dual Check Valves FDA UDI
- Model / Reference
- 200/200 mL EUDAMEDHS-BCD200 EUDAMED100121-A FDA UDI
- Description
- 2-200ml Syringes 2-fill straws 1-72" Y Coiled Tubing with Dual Check Valves FDA UDI
Identifiers
- Catalog Number
- HS-BCD200 FDA UDI
- Primary DI / UDI-DI
- 06938327902209 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327902209 EUDAMED
- 510(k) Number
- K151960 FDA UDI
- FDA Product Code
- DXT FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Angiography kit FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 870.1650 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
Yes
Measuring Function
No
Incorporates Medicinal Product
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
Yes
Category: Angiography kit
This device is a sterile, single-use high-pressure angiographic syringe (Nomenclature Code: A02010401), designed for administering contrast media or other fluids under high pressure during angiographic procedures. It falls under Class IIa risk classification and is intended for use in medical imaging applications requiring precise fluid delivery, such as coronary angiography or interventional radiology.
The syringes are supplied sterile, non-reusable, and non-implantable, with a volume capacity of 200 mL. They are intended for single-use only and must be discarded after use to maintain sterility and safety. The device carries FDA 510(k) clearance (K211564) and complies with the Medical Device Directive (MDD). Proper storage conditions must be followed to preserve sterility, and compatibility with MRI environments is not specified.
Similar devices
Also classified as Angiography kit.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- DeRoyal — DEROYAL INDUSTRIES, INC. · Class II
- NAMIC — NAVILYST MEDICAL, INC.
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
- CARDINAL HEALTH — Cardinal Health 200, LLC · Class II
Frequently asked questions
What is the primary use case for these angiographic syringes in clinical settings?
These syringes are specifically designed for administering contrast media or other fluids under high pressure during angiographic procedures, such as coronary angiography or interventional radiology. Their precision fluid delivery makes them ideal for medical imaging applications requiring controlled contrast injection.
Are these syringes reusable, and if not, why is single-use recommended?
No, these syringes are explicitly intended for single-use only and must be discarded after use. The manufacturer emphasizes this to maintain sterility and safety, as reuse could compromise the sterile barrier and introduce contamination risks, particularly in high-pressure applications where fluid integrity is critical.
What volume capacity does this syringe model offer, and how does that benefit angiographic procedures?
The syringe model (200/200 mL) provides a 200 mL capacity, which is well-suited for angiographic procedures requiring larger volumes of contrast media. This volume allows for extended injections without frequent refilling, improving procedural efficiency and reducing interruptions during critical imaging phases.
How should these syringes be stored to ensure they remain sterile and functional?
The syringes are sterile by design, but proper storage conditions must be followed to preserve sterility and integrity. While specific storage instructions aren’t detailed here, typical practices for sterile single-use devices—such as keeping them in sealed packaging, away from moisture/dust, and at recommended temperature ranges—should be adhered to. Avoid exposure to extreme temperatures or direct sunlight.
Who is the manufacturer, and what regulatory clearances does this device hold?
The manufacturer is Shenzhen Boon Medical Supply Co., Ltd., and the device holds FDA 510(k) clearance (K211564) as well as compliance with the Medical Device Directive (MDD). These clearances confirm the device meets regulatory standards for safety and performance in its intended high-pressure angiographic applications.
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: Shenzhen Boon Medical Supply Co., Ltd., Single-use Sterile High-pressure Angiographic Syringes and Accessories ..., PDF Shenzhen Boon Medical Supply Co., Ltd. Shengyu Fan International ..., Sterile High-pressure Angiographic Syringes for Single-use, Sterile High-pressure Angiographic Syringes for Single-use (K211564 ...
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192657 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K211564 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K182289 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K151960 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-06938327902209 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
- EUDAMED SRN
- CN-MF-000018400
- Authorised Representative
- Wellkang Ltd XI-AR-000001836
Sources (3)
- EUDAMED 6b852194-f0bc-44af-8f18-a233519eba0d 61 fields · synced Sep 18, 2026
- FDA UDI 3001a330-47b7-4060-916f-cd86726f6620 37 fields · synced May 30, 2026
- FDA 510(k) K192657 1 fields · synced May 18, 2026