Search Results
Found 7 results
510(k) Data Aggregation
K Number
K062091Device Name
POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
Manufacturer
POROUS MEDIA CORP.
Date Cleared
2006-08-08
(15 days)
Product Code
BTT
Regulation Number
868.5450Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Humidifiers are defined as a device that is intended to add moisture to the breathing gases for administration to a patient. The HUMIDIFLOW™ is intended to be installed on oxygen concentrators to add moisture to the breathing gases for administration to a patient.
Device Description
The HUMIDIFLOW™ is a new device that humidifies oxygen. The device attaches to the inlet side of the air compressor and to the outlet oxygen used in oxygen concentrators and operates as a mass exchanger to transfer the room air humidity to the patient gas.
Ask a Question
K Number
K061426Device Name
OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
Manufacturer
POROUS MEDIA CORP.
Date Cleared
2006-06-05
(13 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Porous Media oxygen concentrator filters are replacement filters intended for use in oxygen concentrator machines to help remove contaminants, including air borne bacteria and other particulate debris from an air stream. When used with oxygen concentrator machines, the replacement filters may be used in the home, nursing home, patient care facility, etc.
Device Description
Room air is drawn into the compressor through the bacterial intake filter. From the compressor, the air passes through the compressor filter, if one is installed on the machine, and proceeds to the sieve beds. The sieve beds condition the air, by removing nitrogen from the air stream, which results in a higher concentration of oxygen. The air then passes through the final filter before being supplied to the patient.
Ask a Question
K Number
K990276Device Name
POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1999-10-01
(246 days)
Product Code
KRJ
Regulation Number
870.4280Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- The filter is intended for use only with non-cellular fluid in the extra-. corporeal circuit prior to the initiation of cardiopulmonary bypass.
- The DPB30 disposable pre-bypass filter has been designed for single . use and should be discarded once the circuit is primed
- The device is intended for adult population only. .
Device Description
DPB30 Disposable Pre-bypass Filter
Ask a Question
K Number
K982385Device Name
POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1999-02-01
(207 days)
Product Code
KRJ, NOV
Regulation Number
870.4280Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- . THE FILTER IS INTENDED FOR USE ONLY WITH NON-CELLULAR FLUID IN THE EXTRACORPOREAL CIRCUIT PRIOR TO THE INITIATION OF CARDIOPULMONARY BYPASS.
- THE DPB20™ DISPOSABLE PRE-BYPASS FILTER HAS . BEEN DESIGNED FOR SINGLE USE AND SHOULD BE DISCARDED ONCE THE CIRCUIT IS PRIMED.
Device Description
Not Found
Ask a Question
K Number
K982127Device Name
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1998-06-23
(6 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THIS DISPOSABLE FILTER HAS BEEN DESIGNED FOR SINGLE USE AS A MAIN FLOW FILTER, INSPIRATORY AND EXHALATION FILTER. THIS FILTER IS HYDROPHOBIC. FOR USE WITH RESPIRATORY THERAPY AND ANESTHESIA APPLICATIONS. HELPS PROTECT PATIENTS FROM RESPIRATORY AND ANESTHESIA VENTILATOR CONTAMINANTS. VERSATILE, DISPOSABLE, ENCONOMY OF USE - HELPS PROTECT PATIENT, VENTILATORY EQUIPMENT, AND HOSPITAL STAFF.
Device Description
One Disposable Breathing Circuit Bacterial Filter. CLEAR PLASTIC SHELL ALLOWS FOR VISUAL INSPECTION OF THE FILTER MEDIUM.
Ask a Question
K Number
K965020Device Name
POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1997-03-14
(88 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K964979Device Name
POROUS MEDIA DBF23 DISPOSABLE RESPIRATORY FILTER
Manufacturer
POROUS MEDIA CORP.
Date Cleared
1997-03-11
(89 days)
Product Code
CAH
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
POROUS MEDIA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
Page 1 of 1