FDA Registration
Active
🇺🇸 United States
RETROGRADE CARDIOPLEGIA CANNULA (SELF INFLATE) NO STYLET
Reg #: 2244478
·
FEI: 1000136269
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Cosmed Group, Inc., d/b/a Cosmed of NJ
- Registration Number
- 2244478
- FEI Number
- 1000136269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19 PARK DR.
- City
- Franklin
- State
- NJ
- ZIP
- 07416
- Country
- US
Regulatory Submissions
- 510(k) Number
- K964393
Owner / Operator
- Firm Name
- Cosmed Group, Inc.
- Operator Number
- 2244478
- Address
- 28 Narragansett Ave.
- City
- Jamestown
- State
- RI
- Postal Code
- 02835
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | Class 2 | Cardiovascular | No | 2019-12-16 |
Proprietary Names
RETROGRADE CARDIOPLEGIA CANNULA (SELF INFLATE) NO STYLET
RETROGRADE CARDIOPLEGIA CANNULA (SELF INFLATE) SURE TOUCH STYLET
RETROGRADE CARDIOPLEGIA CANNULA (SELF INFLATE) RIGID STYLET
RETROGRADE CARDIOPLEGIA CANNULA (SELF INFLATE) GUIDEWIRE STYLET
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)