FDA Registration
Active
🇺🇸 United States
PASSY-MUIR, INC.
Reg #: 2024841
·
FEI: 2024841
·
Expires 2026
Products
5
Proprietary Names
15
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- PASSY-MUIR, INC.
- Registration Number
- 2024841
- FEI Number
- 2024841
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 17992 Mitchell S Ste 200
- City
- IRVINE
- State
- CA
- ZIP
- 92614
- Country
- US
Regulatory Submissions
- 510(k) Number
- K944451
Owner / Operator
- Firm Name
- PASSY-MUIR, INC.
- Operator Number
- 2024841
- Address
- 17992 MITCHELL SOUTH, SUITE 200
- City
- Irvine
- State
- CA
- Postal Code
- 92614
- Country
- US
- Correspondent
- Cameron M Jolly
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Connector, Airway (Extension) | BZA | Class 1 | Anesthesiology | No | 2015-12-30 |
| Tube Tracheostomy And Tube Cuff | JOH | Class 2 | Anesthesiology | No | 2001-09-26 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2024-11-14 |
| Tube, Tracheostomy (W/Wo Connector) | BTO | Class 2 | Anesthesiology | No | 1993-01-18 |
| Condenser, Heat And Moisture (Artificial Nose) | BYD | Class 1 | Anesthesiology | No | 2025-01-30 |
Proprietary Names
Passy Muir Low-Profile DB15 Adapter PM-DB15
Passy Muir DigiSil Digital (Finger) Occlusion Adapter PM-OCLN
Passy-Muir Tracheostomy & Ventilator Swallowing and Speaking Valve
PMV 007
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Passy-Muir Low-Profile Tracheostomy Swallowing and Speaking Valve
PMV 2020
PMV 005
Passy-Muir Tracheostomy & Ventilator and Speaking Valve
PMV 2001
PMV 2000
Passy-Muir Low-Profile Tracheostomy & Ventilator Swallowing and Speaking Valve
Passy Muir Heat Moisture Exchanger
Passy-Muir Oxygen Adapter
PMA 2000
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device