FDA Registration
Active
🇺🇸 United States
BIO-MED DEVICES, INC.
Reg #: 1218704
·
FEI: 3003952420
·
Expires 2026
Products
6
Proprietary Names
13
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- BIO-MED DEVICES, INC.
- Registration Number
- 1218704
- FEI Number
- 3003952420
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 61 SOUNDVIEW RD
- City
- GUILFORD
- State
- CT
- ZIP
- 06437
- Country
- US
Regulatory Submissions
- 510(k) Number
- K871336
Owner / Operator
- Firm Name
- BIO-MED DEVICES, INC.
- Operator Number
- 1218704
- Address
- 61 SOUNDVIEW RD, --
- City
- Guilford
- State
- CT
- Postal Code
- 06437
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | Class 2 | Anesthesiology | No | 2007-11-30 |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | Class 1 | Anesthesiology | No | 2002-09-11 |
| Ventilator, Continuous, Facility Use | CBK | Class 2 | Anesthesiology | No | 2007-11-30 |
| Mixer, Breathing Gases, Anesthesia Inhalation | BZR | Class 2 | Anesthesiology | No | 2007-11-30 |
| Analyzer, Gas, Oxygen, Gaseous-Phase | CCL | Class 2 | Anesthesiology | No | 2022-11-22 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | Class 1 | Anesthesiology | No | 1999-06-16 |
Proprietary Names
M-1 PRESSURE MONITOR
BIO-MED DEVICES BREATHING CIRCUIT
MVP-10 VENTILATOR
TV-100 Ventilator
CROSSVENT-4+
CROSSVENT VENTILATOR
CROSSVENT-2i+
CROSSVENT-3+
AIR-OXYGEN BLENDER
OxyMinder
M-10 VENT MONITOR
IC-2A VENTILATOR
BIO-MED BREATHING CIRCUIT
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device