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510(k) Data Aggregation
K Number
K012958Device Name
BREATHING CIRCUIT FILTER
Manufacturer
Date Cleared
2002-02-22
(171 days)
Product Code
Regulation Number
868.5260Why did this record match?
Applicant Name (Manufacturer) :
EMERGENCY FILTRATION PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Heat and passive humidification with filtration between patient and circuit. Designed for use with all ISO compliant airway management systems including ventilators, respirators, and open flow systems where filtration of inspired or expired gases is required such as in hospitals, surgical centers, long term healthcare facilities and the home utilizing anesthesiology or respiratory equipment. Place at anytime on the inspiratory and/or expiratory side of the patient circuit. For single patient use only. For sale by or on the order of a physician.
Device Description
The Series 1 Breathing Circuit Filter is a filter device intended to remove microbiological and particulate matter from the gases in a breathing circuit similar to the SIMS Portex, Inc. Breathing Filter and Filtered HME. The Series 1 Breathing Circuit Filter features include the following: Hydrophobic filter media, Hydrophilic filter media, Sonic welded housing, ISO compliant.
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K Number
K980052Device Name
RESPAIDE
Manufacturer
Date Cleared
1998-08-05
(211 days)
Product Code
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
EMERGENCY FILTRATION PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
RespAide™ is designed to be used in an emergency situation where CPR assistance is required. RespAide™ offers to the administrator of CPR the comfort that the risk of transmission of various pathogens is greatly reduced and, therefore, the hesitancy factor for providing CPR is overcome. RespAide™ should be made available to all consumers for office, automobiles, boats, swimming pools, industry, airlines, and anywhere an incident of respiratory or cardiac arrest may occur.
Non Re-Breathing Valve, 73 CBP, Class II under CFR 868.5870 Respiratory assisted device - used in cardiac or respiratory arrest to assist in cardiopulmonary resuscitation (CPR).
Device Description
Emergency Filtration Products, Inc. wishes to introduce to the market the RespAide™ air filtering CPR assistance mask, a device similar to the Laerdal pocket mask. Both products are one way valve, CPR assistance masks.
RespAide™ features include the following:
- One Way Valve with Hydrophobic and Hydrophilic Filters .
- Pillow Mask
- ISO Fittings
- Nylon Stuff Sack .
- Mouthpiece .
- Latex Gloves ●
- Antiseptic Wipe ●
- Biohazard Bag for disposal after use
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