Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012395857

FEI Number

3012395857

Entity Name

Shenzhen Boon Medical Supply Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District, Shenzhen Guangdong 518173, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Boon Medical Supply Co., Ltd (Owner Number: 10051055)

Owner / Operator Contact Address

No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District, Shenzhen, CN-GD 518173, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241109

PMA Number

N/A

All Registered Proprietary Names

Models:100101, 100103, 100104, 100111, 100113, Models:100114, 100121, 100124, 200101, 200102, 200103 Sterile High-pressure Angiographic Syringes for Single-use 500109-1 high-pressure connection tube(1500mm) 400104-1 line connection tube with two valves(1500mm) 700104-1 Puncture 400101-4 screw connection tube with valve(1500mm) 700101 long spike 400101-8 line connection tube with valve and screw union(200mm) 500109-2 high-pressure connection tube(1500mm) 400102-5 Y shape screw tube with two valves(1500mm) 500107-1 high-pressure connection tube(1000mm) 600101-1 T shape screw tube with valve(2500mm)2 400101-7 line connection tube with valve(200mm) 400102-3 Y shape screw tube with valve(1500mm) 400103-4 T shape screw tube with valve(1800mm) 400102-4 Y shape line tube with two valves(1500mm) 500110-1 high-pressure connection tube(1800mm) 400102-7 Y shape screw tube with valve(1800mm) 400101-6 screw connection tube with valve(1800mm) 400102-2 Y shape line tube with valve(1500mm) Models:200104, 300101, 300103 and 300105 400103-1 T shape line tube with valve(1500mm) 400102-9 Y shape screw tube with two valves(1800mm) 400101-1 line connection tube(1500mm) 700107-1 1-21" Transfer Set with C Clamp and Swabable Valve 400103-3 T shape line tube with valve(1800mm) 700104-2 Puncture 600101-1 T shape line tube with valve(2500mm) 400101-5 line connection tube with valve(1800mm) 400101-3 line connection tube with valve(1500mm) 500105-1 high-pressure connection tube(500mm) 400104-2 line connection tube with two valves(1800mm) 600102-2 Y shape screw tube with two valves(2500mm) 500110-2 high-pressure connection tube(1800mm) 400103-2 T shape screw tube with valve(1500mm) 400102-6 Y shape line tube with valve(1800mm) 700105-2 Puncture 700105-1 Puncture 400102-1 Y shape tube with two valves(200mm) 500107-2 high-pressure connection tube(1000mm) 700103 Suction tube 500108-1 high-pressure connection tube(1200mm) 400101-2 screw connection tube(1500mm) 500108-2 high-pressure connection tube(1200mm) 400102-8 Y shape line tube with two valves(1800mm) 500106-2 high-pressure connection tube(750mm) 600102-1 Y shape line tube with two valves(2500mm) 500106-1 high-pressure connection tube(750mm) Models:100108B,100109A,100109B,100119A,100119B,200104B,200104C 700102 short spike 500105-2 high-pressure connection tube(500mm) 700107-2 1-21" Transfer Set with C Clamp and Swabable Valve and Ball Check Valve Spike 700106-1 1-9"Transfer Set with C Clamp 700106-2 1-21" Transfer Set with C Clamp Boon Transfer set, Models: 700204-1, 700204-2, 700205-1, 700205-2, 700206, 700207-1, 700207-2 Connection tube, Models: 400204 Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 100123, 100125, 100110, 100120, 100112, 100122 Sterile High-Pressure Angiographic Syringes For Single-Use, Models: 300107, 200105, 200113, 200110, 200111

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2016-01-28
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2021-10-25
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2025-05-20

Official Correspondent

No official correspondent registered.

US Agent Details

Ann Hamilton Ruben Business: Darco International Corporation Email: Ahr@Darcointernational.net Phone: (954) 3808595

Related Public Records

Same Entity

Shenzhen Boon Medical Supply Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2008	Lemaitre Vascular, Inc.	2	CVI OZ Palm Injector, used to perfuse contrast media into vessels for angiographic procedures. Ref : OZ 1035 (Cardiovascular Innovations LLC)
Z-0039-05	Medrad Inc	2	Stellant Syringe Kit. Sterile Disposable Syringe Kits. CT Injector and Accessories. Catalog number SSS-CTP-QFT

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012395857. Last updated year: 2026. Please use registration number 3012395857 when referencing this establishment in official correspondence.