FDA Registration
Active
🇨🇳 China
First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter
Reg #: 3007963782
·
FEI: 3007963782
·
Expires 2025
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Koo (Shanghai) Industries Co., Ltd
- Registration Number
- 3007963782
- FEI Number
- 3007963782
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 100 Zhongde Road, Xiaokunshan Town
- City
- Songjiang Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- KOO MFG, INC.
- Operator Number
- 9012237
- Address
- 100 Zhongde Road, Dakun Indurstrial Park
- City
- Songjiang
- State
- Shanghai
- Postal Code
- 201613
- Country
- CN
- Correspondent
- CHRISTOPHER - KOO
US Agent
- Business Name
- Promedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2005-07-29 |
Proprietary Names
First Breath Nasal Oxygen Cannula with gas monitoring line, female luer connector, tubing, oxygen adapter
First Breath Nasal Oxygen Cannula with gas monitoring line, male luer connector, tubing, oxygen adapter
First Breath Nasal Oxygen Cannula with ETCO2 monitoring
First Breath Nasal Oxygen Cannula with male luer connector, tubing and oxygen connector
First Breath Nasal Oxygen Cannula with female luer connector, tubing and oxgyen adapter
OXYGEN NASAL CANNULA
Establishment Types
Manufacture Medical Device