FDA Registration
Active
🇲🇽 Mexico
CARTRIDGE BLOOD SET
Reg #: 8030638
·
FEI: 3002806727
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- GAMBRO RENAL PRODUCTS S.A. DE C.V.
- Registration Number
- 8030638
- FEI Number
- 3002806727
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- BLVD PACIFICO 10014, PARQUE INDUSTRIAL PACIFICO
- City
- TIJUANA Baja California
- Country
- MX
Regulatory Submissions
- 510(k) Number
- K100364
Owner / Operator
- Firm Name
- Vantive US Healthcare LLC
- Operator Number
- 9038727
- Address
- One Baxter Parkway, Building 6
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Jennifer Masek-Little
US Agent
- Business Name
- Baxter Healthcare Corporation
- Contact Name
- Jennifer Masek-Little
- Address
- 25212 W Il Route 120
- City
- Round Lake
- State
- IL
- ZIP
- 60073
- Country
- US
- [email protected]
- Phone
- 224 2707027
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Set, Tubing, Blood, With And Without Anti-Regurgitation Valve | FJK | Class 2 | Gastroenterology, Urology | No | 2010-11-04 |
Proprietary Names
CARTRIDGE BLOOD SET
Establishment Types
Manufacture Medical Device