FDA Registration
Active
🇺🇸 United States
Continuum Primary MR Administration Kit
Reg #: 2520313
·
FEI: 2520313
·
Expires 2025
Products
1
Proprietary Names
3
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Bayer Medical Care Inc.
- Registration Number
- 2520313
- FEI Number
- 2520313
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1 Bayer Drive
- City
- INDIANOLA
- State
- PA
- ZIP
- 15051
- Country
- US
Regulatory Submissions
- 510(k) Number
- K073051
Owner / Operator
- Firm Name
- Bayer Medical Care Inc.
- Operator Number
- 2520313
- Address
- 1 Bayer Drive
- City
- Indianola
- State
- PA
- Postal Code
- 15051
- Country
- US
- Correspondent
- Troy A Jack
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pump, Infusion | FRN | Class 2 | General Hospital | No | 2008-06-20 |
Proprietary Names
Continuum Primary MR Administration Kit
Continuum Secondary MR Administration Kit
Continuum MR Infusion System with Wireless Remote
Establishment Types
Complaint File Establishment per 21 CFR 820.198