FDA Registration
Active
🇨🇳 China
CPR Mask with Oxygen Port
Reg #: 3012034017
·
FEI: 3012034017
·
Expires 2025
Products
1
Proprietary Names
7
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- Heaven Healthcare Co., Ltd.
- Registration Number
- 3012034017
- FEI Number
- 3012034017
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Room 1905,Xingyuan Int'l Bldg,, Yuecheng District,Shaoxing,China
- City
- Shaoxing Zhejiang
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K171961
Owner / Operator
- Firm Name
- Heaven Healthcare Co., Ltd.
- Operator Number
- 10050953
- Address
- Room 1905,Xingyuan Int'l Bldg,, Yuecheng District,Shaoxing,China
- City
- Shaoxing
- State
- Zhejiang
- Postal Code
- 312000
- Country
- CN
- Correspondent
- Jun Yu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Valve, Non-Rebreathing | CBP | Class 2 | Anesthesiology | No | 2024-11-14 |
Proprietary Names
CPR Mask with Oxygen Port
CPR Resuscitator
CPR Mask without Oxygen Port
Infant CPR Mask with Oxygen Port
Non-Rebreathing Valve (18.5mm)
CPR Mask
Non-Rebreathing Valve (15mmOD)
Establishment Types
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device