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Passy-Muir, Inc.

United States·US-MF-000002288

Last updated September 17, 2026

Information

Country
United States
Address
17992, Mitchell South, Irvine, United States
LinkedIn
—
Facebook
—
Phone
9498338255
PRRC Contact
Donna Malter
EUDAMED SRN
US-MF-000002288
FDA FEI Number
2024841
DUNS Number
174508630

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
Passy-Muir PMV-AD22
FDA UDI
Class IActive
Passy-Muir PM-OCLN
FDA UDI
Class IActive
Passy-Muir PMV-AD1522
FDA UDI
Class IActive
Passy-Muir PM-DB15
FDA UDI
Class IActive
Passy-Muir PM-APF15
FDA UDI
Class IIActive
Passy-Muir PMV-AD22
FDA UDI
Class IActive
Passy Muir PM-HME
FDA UDI
Class IActive
Passy-Muir Tracheostomy Speaking Valves (one-Way Tracheostomy Speaking Valves) K944451
FDA 510(k)
Class IIActive
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) K230483
FDA 510(k)
Class IIActive
Passy-Muir O2 Adapter; Pma2000 K970365
FDA 510(k)
Class IIActive
PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 007 (Aqua Color™) PMV 007
EUDAMEDFDA UDI
Class IIaActive
PASSY-MUIR™ TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 005 (white) PMV 005
EUDAMEDFDA UDI
Class IIaActive
PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2000 (clear) PMV 2000
EUDAMEDFDA UDI
Class IIaActive
PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY SWALLOWING AND SPEAKING VALVE PMV™ 2020 (clear) PMV 2020
EUDAMEDFDA UDI
Class IActive
PASSY-MUIR™ LOW PROFILE TRACHEOSTOMY & VENTILATOR SWALLOWING AND SPEAKING VALVE PMV™ 2001 (Purple Color™) PMV 2001
EUDAMEDFDA UDI
Class IIaActive
Passy-Muir™ Valve Oxygen Adapter (PMA™ 2000) PMA 2000
EUDAMEDFDA UDI
Class IIaActive

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