FDA Registration
Active
🇵🇱 Poland
ONE-CARE GLIDE & LOCK Safety Blood Collection Wing Sets
Reg #: 3015485283
·
FEI: 3015485283
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- MEDIVENA SP. Z O.O.
- Registration Number
- 3015485283
- FEI Number
- 3015485283
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Aleja Jana Pawla II 27
- City
- Warszawa Mazowieckie
- Country
- PL
Regulatory Submissions
- 510(k) Number
- K172763
Owner / Operator
- Firm Name
- MediVena Sp. z o.o.
- Operator Number
- 10090324
- Address
- Aleja Jana Pawla II 27
- City
- Warszawa
- State
- Mazowieckie
- Postal Code
- 00-867
- Country
- PL
US Agent
- Business Name
- MediVena
- Contact Name
- Jaroslaw Moleda
- Address
- 1 Glenlake Parkway, Suite 700
- City
- Atlanta
- State
- GA
- ZIP
- 30328
- Country
- US
- [email protected]
- Phone
- 404 4221513
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2025-03-10 |
Proprietary Names
ONE-CARE GLIDE & LOCK Safety Blood Collection Wing Sets
Establishment Types
Foreign Private Label Distributor
Export Device to the United States But Perform No Other Operation on Device