Identity
- Trade Name
- Sterile High-pressure Angiographic Syringes for Single-use EUDAMEDMED-RX FDA UDI
- Generic Name
- Angiography kit FDA UDI
- Device Name
- Sterile High-pressure Angiographic Syringes for Single-use Accessory EUDAMED1-21'' Transfer Set with Swabbable Valve(DEHP-free) FDA UDI
- Model / Reference
- 21 Inch EUDAMED10-1304 EUDAMED700207-1A FDA UDI
- Description
- 1-21'' Transfer Set with Swabbable Valve(DEHP-free) FDA UDI
Identifiers
- Catalog Number
- 10-1304 FDA UDI
- Primary DI / UDI-DI
- 06938327901356 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06938327901356 EUDAMED
- 510(k) Number
- K241109 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Category: Angiography kit
Med-Rx by Shenzhen Boon Medical Supply Co., Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K241109 also covers:
- Guerbet — Shenzhen Boon Medical Supply Co., Ltd.
- MED-RX — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- Sinton Medical Products — Shenzhen Boon Medical Supply Co., Ltd.
- SpectraVue — Shenzhen Boon Medical Supply Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Boon Medical Supply Co., Ltd.
Sources (2)
- FDA UDI 71f4476a-abf6-4828-83c3-64afccc484b0 37 fields · synced Jul 8, 2026
- EUDAMED e4448c7c-1035-4cc7-8b26-ce7b512f1b92 61 fields · synced Jun 18, 2026