FDA Registration
Active
🇨🇳 China
400101-7 line connection tube with valve(200mm)
Reg #: 3012395857
·
FEI: 3012395857
·
Expires 2025
Products
1
Proprietary Names
55
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Shenzhen Boon Medical Supply Co., Ltd.
- Registration Number
- 3012395857
- FEI Number
- 3012395857
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K151960
Owner / Operator
- Firm Name
- Shenzhen Boon Medical Supply Co., Ltd
- Operator Number
- 10051055
- Address
- No.18 Jirong Road, Shenkeng, Henggang Street, Longgang District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518173
- Country
- CN
US Agent
- Business Name
- Darco International Corporation
- Contact Name
- Ann Hamilton Ruben
- Address
- 510 Shotgun Road Ste. 520
- City
- Sunrise
- State
- FL
- ZIP
- 33326
- Country
- US
- [email protected]
- Phone
- 954 3808595
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Injector And Syringe, Angiographic | DXT | Class 2 | Cardiovascular | No | 2016-01-28 |
Proprietary Names
400101-7 line connection tube with valve(200mm)
Models:200104, 300101, 300103 and 300105
400103-2 T shape screw tube with valve(1500mm)
400101-3 line connection tube with valve(1500mm)
700103 Suction tube
500109-1 high-pressure connection tube(1500mm)
400104-1 line connection tube with two valves(1500mm)
400102-6 Y shape line tube with valve(1800mm)
400101-6 screw connection tube with valve(1800mm)
400102-5 Y shape screw tube with two valves(1500mm)
400103-1 T shape line tube with valve(1500mm)
400102-9 Y shape screw tube with two valves(1800mm)
700104-2 Puncture
500110-2 high-pressure connection tube(1800mm)
500110-1 high-pressure connection tube(1800mm)
500105-1 high-pressure connection tube(500mm)
Models:100101, 100103, 100104, 100111, 100113,
500108-2 high-pressure connection tube(1200mm)
Models:100114, 100121, 100124, 200101, 200102, 200103
700105-2 Puncture
700105-1 Puncture
600101-1 T shape line tube with valve(2500mm)
400101-5 line connection tube with valve(1800mm)
400102-7 Y shape screw tube with valve(1800mm)
400102-1 Y shape tube with two valves(200mm)
500107-2 high-pressure connection tube(1000mm)
400102-2 Y shape line tube with valve(1500mm)
500109-2 high-pressure connection tube(1500mm)
400101-1 line connection tube(1500mm)
400104-2 line connection tube with two valves(1800mm)
700101 long spike
400102-4 Y shape line tube with two valves(1500mm)
600102-2 Y shape screw tube with two valves(2500mm)
700104-1 Puncture
400101-4 screw connection tube with valve(1500mm)
Sterile High-pressure Angiographic Syringes for Single-use
500106-1 high-pressure connection tube(750mm)
600102-1 Y shape line tube with two valves(2500mm)
500107-1 high-pressure connection tube(1000mm)
600101-1 T shape screw tube with valve(2500mm)2
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
400103-3 T shape line tube with valve(1800mm)
400102-8 Y shape line tube with two valves(1800mm)
500106-2 high-pressure connection tube(750mm)
400101-8 line connection tube with valve and screw union(200mm)
400102-3 Y shape screw tube with valve(1500mm)
400103-4 T shape screw tube with valve(1800mm)
500108-1 high-pressure connection tube(1200mm)
400101-2 screw connection tube(1500mm)
700106-1 1-9"Transfer Set with C Clamp
Models:100108B,100109A,100109B,100119A,100119B,200104B,200104C
700106-2 1-21" Transfer Set with C Clamp
700107-1 1-21" Transfer Set with C Clamp and Swabable Valve
Establishment Types
Manufacture Medical Device