FDA Registration
Inactive
🇺🇸 United States
PRISMAFLEX M150 SET
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Vantive US Healthcare LLC
- Status
- Inactive
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 510 Lake Cook Rd
- City
- Deerfield
- State
- IL
- ZIP
- 60015
- Country
- US
Regulatory Submissions
- 510(k) Number
- K080519
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
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Dialyzer, High Permeability With Or Without Sealed Dialysate System | KDI | Class 2 | Gastroenterology, Urology | No | 2008-10-07 |
Proprietary Names
PRISMAFLEX M150 SET
Establishment Types
Complaint File Establishment per 21 CFR 820.198