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Disposable High Pressure Syringe

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K170279Ref MDN 1202Ref MDN 1202

by Union Medical Shenzhen Co., Ltd.

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 EUDAMED
SLF302 FDA UDI

Identifiers

Primary DI / UDI-DI
06970286903378 EUDAMED
06970286903507 EUDAMED
06970286903408 EUDAMED
06970286903255 EUDAMED
06970286903033 EUDAMED
06970286903538 EUDAMED
06970286903194 EUDAMED
06970286903026 EUDAMED
06970286903095 EUDAMED
06970286903187 EUDAMED
06970286903231 EUDAMED
06970286903156 EUDAMED
06970286903545 EUDAMED
06970286903088 EUDAMED
06970286903262 EUDAMED
06970286903101 EUDAMED
06970286903279 EUDAMED
06970286903071 EUDAMED
06970286903019 EUDAMED
06970286903521 EUDAMED
06970286903590 EUDAMED
06970286903316 EUDAMED
06970286903118 EUDAMED
06970286903514 EUDAMED
06970286903354 EUDAMED
06970286903200 EUDAMED
06970286903330 EUDAMED
06970286900575 FDA UDI
Basic UDI-DI
697028690SyringeHJ EUDAMED
B-06970286903026 EUDAMED
510(k) Number
K170279 FDA 510(k)FDA UDI
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 EUDAMED
Class 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 EUDAMED
Finland 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

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

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

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Sources (29)

  • FDA 510(k) K170279 24 fields · synced Sep 30, 2026
  • FDA UDI 502cb166-305e-4bea-9d32-757f04add4a9 33 fields · synced May 26, 2026
  • EUDAMED a1512944-06cb-4cf1-b67d-a616db8b7649 61 fields · synced Jul 8, 2026
  • EUDAMED 45275281-1ab5-4956-9461-393d01ff27f0 61 fields · synced Jul 9, 2026
  • EUDAMED bbd5dc62-ebca-4a39-9480-538e2e01d385 61 fields · synced Jul 9, 2026
  • EUDAMED f7989d6b-3c63-4c98-97e0-495f6ff5b46a 61 fields · synced Jul 9, 2026
  • EUDAMED 55fa82c4-5375-4627-bfb0-ae5caf2f442d 61 fields · synced Jul 9, 2026
  • EUDAMED af56f704-9992-4772-9725-2916ac1df728 61 fields · synced Jul 9, 2026
  • EUDAMED afb21ee4-3fe3-49b2-ba37-48d96514c6d4 61 fields · synced Jul 12, 2026
  • EUDAMED a588fe04-bfd7-4902-ae7d-835362a1aa0d 61 fields · synced Jul 12, 2026
  • EUDAMED cb63d72e-0ae3-4f1a-ba78-db83c1b71527 61 fields · synced Jul 15, 2026
  • EUDAMED 07d0c702-6a19-4ef0-9a5e-b9977ae92e3f 61 fields · synced Jul 15, 2026
  • EUDAMED 40e733e2-3e46-44c0-a88c-c9964a234a77 61 fields · synced Jul 15, 2026
  • EUDAMED fce0a146-5e9e-4e8e-bb35-35151076eb31 61 fields · synced Jul 16, 2026
  • EUDAMED 57c4bf7e-523a-49fe-a66a-23f6a2ea3b28 61 fields · synced Jul 17, 2026
  • EUDAMED 375aed8b-7e52-49ea-8bc1-1e2d45a300c6 61 fields · synced Jul 19, 2026
  • EUDAMED df7065b9-678c-4db8-8765-221c50ce17c3 61 fields · synced Jul 21, 2026
  • EUDAMED f04b8007-7bfb-47f5-8c52-59282624e17d 61 fields · synced Jul 22, 2026
  • EUDAMED 3c55fe95-4293-40a1-b52b-b5581e19929c 61 fields · synced Jul 24, 2026
  • EUDAMED 72978fa2-07a2-45af-acc0-28c9429e273f 61 fields · synced Jul 24, 2026
  • EUDAMED f981aa02-0f0c-4171-afac-ecc6d22c79a7 61 fields · synced Jul 26, 2026
  • EUDAMED e5fbfa20-580e-4fac-b24f-fd11360a54c1 61 fields · synced Jul 27, 2026
  • EUDAMED 68d8d9c9-3eb6-4448-b726-e9cff9d0ec15 61 fields · synced Jul 29, 2026
  • EUDAMED 34fd7805-a1e0-4eb9-ad71-89e7029c67f3 61 fields · synced Jul 31, 2026
  • EUDAMED 53832bae-f12b-463f-93c8-ecfa159ea3b8 61 fields · synced Aug 1, 2026
  • EUDAMED 355d669c-d1d1-47e4-ae95-645594606dba 61 fields · synced Aug 2, 2026
  • EUDAMED 2005f210-bc11-46ef-ab4f-4aaae3816954 61 fields · synced Aug 2, 2026
  • EUDAMED acccc665-28e2-4fa8-9843-68cb9bc2c29a 61 fields · synced Aug 4, 2026
  • EUDAMED 159b21f7-2d6e-4878-b26b-cbc759efe01b 61 fields · synced Sep 18, 2026