FDA Registration
Active
🇺🇸 United States
HANS RUDOLPH, INC.
Reg #: 1922553
·
FEI: 1922553
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- HANS RUDOLPH, INC.
- Registration Number
- 1922553
- FEI Number
- 1922553
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 8325 COLE PKWY
- City
- Shawnee
- State
- KS
- ZIP
- 66227
- Country
- US
Regulatory Submissions
- 510(k) Number
- K030822
Owner / Operator
- Firm Name
- HANS RUDOLPH, INC.
- Operator Number
- 1922553
- Address
- 8325 Cole Parkway, --
- City
- Shawnee
- State
- KS
- Postal Code
- 66227
- Country
- US
- Correspondent
- KEVIN A RUDOLPH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2008-01-24 |
| Mask, Oxygen | BYG | Class 1 | Anesthesiology | No | 1996-07-16 |
| Calibrator, Volume, Gas | BXW | Class 1 | Anesthesiology | No | 1992-12-22 |
| Ventilator, Non-Continuous (Respirator) | BZD | Class 2 | Anesthesiology | No | 2007-12-28 |
| Mask, Oxygen, Non-Rebreathing | KGB | Class 1 | Anesthesiology | No | 2002-08-23 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2007-12-28 |
Proprietary Names
Metro Seal
NASAL CPAP MASK
RUDOLPH F. R. C. CALIBRATION AID
RUDOLPH CALIBRATED VARIABLE VOLUME
RUDOLPH CALIBRATED SUPER SYRINGE
Oro-Nasal CPAP Mask
V2 FACE MASK
Oro-Nasal NIV Mask
Establishment Types
Manufacture Medical Device