Disposable High Pressure Syringe
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Disposable High Pressure Syringe EUDAMEDFDA UDI
- Generic Name
- Angiographic syringe FDA UDI
- Device Name
- Disposable high pressure syringe EUDAMED
- Model / Reference
- MDN 1202 EUDAMEDSLF302 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06970286903378 EUDAMED06970286903507 EUDAMED06970286903408 EUDAMED06970286903255 EUDAMED06970286903033 EUDAMED06970286903538 EUDAMED06970286903194 EUDAMED06970286903026 EUDAMED06970286903095 EUDAMED06970286903187 EUDAMED06970286903231 EUDAMED06970286903156 EUDAMED06970286903545 EUDAMED06970286903088 EUDAMED06970286903262 EUDAMED06970286903101 EUDAMED06970286903279 EUDAMED06970286903071 EUDAMED06970286903019 EUDAMED06970286903521 EUDAMED06970286903590 EUDAMED06970286903316 EUDAMED06970286903118 EUDAMED06970286903514 EUDAMED06970286903354 EUDAMED06970286903200 EUDAMED06970286903330 EUDAMED06970286900575 FDA UDI
- Basic UDI-DI
- 697028690SyringeHJ EUDAMEDB-06970286903026 EUDAMED
- 510(k) Number
- FDA Product Code
- DXT FDA 510(k)FDA UDI
- EMDN Code
- A02010401 SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE EUDAMED
- GMDN Term
- Angiographic syringe FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 870.1650 FDA 510(k)
- Regulation Number
- 870.1650 FDA 510(k)FDA UDI
- Market of Registration
- Germany EUDAMEDFinland EUDAMED
- Advisory Committee
- Cardiovascular 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
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
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
The Disposable High Pressure Syringe is a single-use injector and syringe designed for angiographic procedures. It delivers precise, high-pressure fluid injections, facilitating contrast media delivery in cardiovascular imaging and interventions.
This device is supplied as a sterile, disposable item and is classified as a Class II medical device under FDA regulations. It is intended for single-use only and must be discarded after use to ensure sterility and patient safety. The syringe is compatible with MRI environments and is available in multiple sizes as referenced in the regulatory filings.
Frequently asked questions
What types of procedures is this syringe specifically designed for, and why is high-pressure delivery important in those contexts?
This syringe is designed for angiographic procedures, which involve injecting contrast media to visualize blood vessels during cardiovascular imaging and interventions. High-pressure delivery is critical in these procedures because it ensures the contrast agent is pushed through narrow or resistant vessels, providing clear and immediate visualization of the vascular structures. This clarity is essential for accurate diagnosis and effective treatment planning in procedures like coronary angiography or peripheral vascular imaging.
Is this syringe compatible with MRI environments, and if so, how does that affect its use in clinical settings?
Yes, the syringe is explicitly stated as compatible with MRI environments. This compatibility means it can be safely used in magnetic resonance imaging procedures without interfering with the MRI machine’s magnetic field or causing artifacts. For clinicians, this eliminates the need for alternative injectors during combined angiographic and MRI studies, streamlining workflow and ensuring consistent imaging quality.
How should this syringe be stored, and what precautions should be taken to maintain its sterility and performance?
Since the syringe is sterile and intended for single-use only, it should be stored in its original packaging until use to preserve sterility. The packaging should be kept in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing the syringe to moisture or contamination, as this could compromise its integrity and safety for use in angiographic procedures. Always follow manufacturer guidelines for storage to ensure optimal performance and patient safety.
Are there multiple sizes available for this syringe, and how do I determine which size is appropriate for my procedure?
Yes, the syringe is available in multiple sizes, as referenced in the regulatory filings (e.g., FEI numbers provided). The appropriate size depends on the volume of contrast media required for the specific angiographic procedure and the patient’s vascular anatomy. Larger volumes or more resistant vessels may require higher-capacity syringes, while smaller volumes or delicate procedures may benefit from lower-capacity options. Consult the manufacturer’s documentation or your radiology team to select the correct size for your clinical needs.
Why is it important that this syringe is labeled as single-use only, and what happens if it is reused?
The syringe is labeled as single-use only to ensure sterility and patient safety. Reusing a syringe violates sterility protocols, as it exposes the device to potential contamination from the patient’s blood or other bodily fluids, increasing the risk of infection or device failure. Additionally, reuse can compromise the syringe’s structural integrity, leading to leaks or inaccurate fluid delivery during high-pressure injections. Adhering to single-use guidelines is essential for maintaining procedural safety and reliability.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K170279 | Class II | Active |
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Manufacturer
- Manufacturer
- Union Medical Shenzhen Co., Ltd.
Sources (29)
- FDA 510(k) K170279 24 fields · synced Sep 30, 2026
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