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510(k) Data Aggregation
K Number
K230483Device Name
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Manufacturer
Passy-Muir, Inc.
Date Cleared
2023-09-16
(205 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
Passy-Muir, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To filter a patient's inspiratory and expiratory respiratory gasses to remove bacteria and viruses.
For non-mechanically ventilated tracheostomy patients who are awake and alert or monitored by a trained healthcare provider or caregiver, where filtration of inspired and/or expired gases is desired. Use up to 24 hours.
Environment of use - clinical settings including hospital, sub-acute, pre-hospital, and home. For adults with Tidal Volumes >300 ml and pediatrics with Tidal Volumes >80 ml. Do not use on neonate or infant patients.
Device Description
The Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) is a non-sterile, lightweight, single-patient use device for non-mechanically ventilated tracheostomy patients to filter viral, bacterial, and other particulate matter. The filter is intended to fit onto the 15mm hub of a tracheostomy tube. The filter is easy to apply and remove with a gentle twist motion.
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K Number
K990905Device Name
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
Manufacturer
PASSY-MUIR, INC.
Date Cleared
1999-06-11
(85 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PASSY-MUIR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PMV 2020 (Clear) JIT is designed to be used in conjunction with the Passy-Muir Adapter PMA-S JIT 4-6 for use on the Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4, #5 and #6 or equivalent in providing vocalization without finger occlusion for both short-term and long-term tracheostomized patients. It is appropriate for neonatal, pediatric and adult patients and is ideal for use in decannulation as an assessment device for physicians, as well as providing the patient comfort and confidence in upper airway usage. The PMV 2020 (Clear) JIT Valve is also designed to be used without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
Indications for Use - Including but not limited to the following:
- For Sleep Apnea patients who are tracheostomized as an alternative to plugging when awake
- Bilateral Vocal Cord Paralysis without significant airway obstruction
- Tracheomalacia
- Mild Tracheal and Laryngeal Stenosis
- Non-Obstructive Laryngeal Tumors (can include patients who have intact vocal cords following surgical resection of the tumor)
- Neuromuscular Disease
- Chronic Obstructive Pulmonary Disease
- Brain Injury
- Non-Ventilator Dependent Quadriplegics
- Patients who emotionally or physically are unable to tolerate plugging
Device Description
Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) JIT to be used in conjunction with the Passy-Muir Adapter PMA 2020-S JIT 4-6 for use on Pilling Weck metal Jackson Improved tracheostomy tubes sizes #4. #5 and #6 or equivalent, and also for use without an adapter on the Bivona (Non-Foam Filled Cuffed) tracheostomy tubes currently on the market.
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K Number
K970365Device Name
PASSY-MUIR O2 ADAPTER; PMA2000
Manufacturer
PASSY-MUIR, INC.
Date Cleared
1997-02-12
(12 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PASSY-MUIR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The P-M O2 Adapter is designed for use with the companion PMV 2000 (clear) and PMV 2001 (purple) Low Profile Tracheostomy and Ventilator Speaking Valves. The P-M O2 Adapter allows for improved mobility of those patients requiring a tracheostomy tube, speaking valve, and low flow supplemental oxygen.
Device Description
The Passy-Muir O2 Adapter is a one-piece, injection-molded plastic device designed to attach to the outer surface of either one of the Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valves (PMV 2000 or PMV 2001) and provide a means for connecting a supplemental oxygen supply tube
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K Number
K962714Device Name
PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
Manufacturer
PASSY-MUIR, INC.
Date Cleared
1996-10-28
(108 days)
Product Code
JOH
Regulation Number
868.5800Why did this record match?
Applicant Name (Manufacturer) :
PASSY-MUIR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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