FDA Registration
Active
🇺🇸 United States
HILL-ROM, INC.
Reg #: 2027454
·
FEI: 2027454
·
Expires 2026
Products
4
Proprietary Names
5
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- HILL-ROM, INC.
- Registration Number
- 2027454
- FEI Number
- 2027454
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1501 Nowell Road
- City
- Raleigh
- State
- NC
- ZIP
- 27607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171056
Owner / Operator
- Firm Name
- BAXTER HEALTHCARE CORPORATION
- Operator Number
- 1417572
- Address
- One Baxter Parkway
- City
- Deerfield
- State
- IL
- Postal Code
- 60015
- Country
- US
- Correspondent
- Maha Nolasco
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Bed Patient | KMI | Class 1 | General Hospital | No | 2022-01-10 |
| System, Communication, Powered | ILQ | Class 2 | Physical Medicine | No | 2022-01-10 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-10 |
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2022-01-10 |
Proprietary Names
Voalte Smart Sync OR NaviCare V4.1
Voalte Patient Safety OR NaviCare Patient Safety V4.1
Voalte Nurse Call OR NaviCare Nurse Call V4.1
WAVE Clinical Platform
WAVE Clinical Platform (200)
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device