FDA.reportPublic FDA data

PASSY-MUIR, INC.

Matched from indexed company URL: Passy-Muir, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20248412024841PASSY-MUIR, INC.1N2026-01-0117992 Mitchell S Ste 200 IRVINE CA US 92614

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00859760005059Passy Muir - Passy Muir Heat Moisture Exchanger9498338255info@passymuir.com
10859760005001Passy-Muir - Passy-Muir® Tracheostomy Viral & Bacterial Airway Protection Filter9498338255info@passymuir.com
10859760005056Passy Muir - Passy Muir Heat Moisture Exchanger9498338255info@passymuir.com
10859760005070Passy-Muir - Passy Muir Low-Profile DB15 Adapter9498338255info@passymuir.com
10859760005094Passy-Muir - Passy Muir DigiSil Digital (Finger) Occlusion Adapter9498338255info@passymuir.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
50091603825213K990905PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JITJOH1999-06-11
50091612103712K970365PASSY-MUIR O2 ADAPTER; PMA2000JOH1997-02-12
50091560178380K962714PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000JOH1996-10-28
50091260646970K944451PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)JOH1995-07-07
50091072344497K903699PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MMJOH1990-09-04
50092003740160K851016PASSY-MUIR TRACH VALVEBTO1985-06-07
50091184681338K230483Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH2023-09-16
50091048534197
50091224278454
50091446916962

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOH51999-06-11
CAH12023-09-16
BTO11985-06-07

PMN#

GUDID#