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510(k) Data Aggregation
K Number
K112126Device Name
GENUINE FIRST AID CPR MASK
Manufacturer
GENUINE FIRST AID LLC
Date Cleared
2011-12-01
(129 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
GENUINE FIRST AID LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CPR mask (without oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Device Description
Genuine First Aid CPR Face Mask without oxygen port, is made up of medical grade PVC and one-way valve of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use, CPR mask includes: One-way filter valve PVC mask without oxygen port Elastic Strap Packaged for easy portability and quick access
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K Number
K102299Device Name
CPR FACE MASK
Manufacturer
GENUINE FIRST AID LLC
Date Cleared
2011-03-18
(217 days)
Product Code
CBP
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
GENUINE FIRST AID LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Genuine First Aid CPR Face (with oxygen port) is single use designed for mouth to mask ventilation to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing adult. It is also used as a barrier that will direct expired air from the patient away from the user. This device should only be used by persons who have received adequate training.
Device Description
Genuine First Aid CPR Face Mask and oxygen port, made up of medical grade PVC and one-way valve made up of medical grade K-resin. The mask is used for mouth-to-mask breathing. There is a shield between the person who gives respiration and the victim. Single use. CPR mask includes: One-way filter valve PVC mask with oxygen port Elastic Strap Packaged for easy portability and quick access
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