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510(k) Data Aggregation
K Number
K960587Device Name
CPROTECTOR 2000
Manufacturer
Date Cleared
1997-07-21
(525 days)
Product Code
Regulation Number
868.5870Why did this record match?
Applicant Name (Manufacturer) :
CERTIFIED SAFETY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
A physical barrier for mouth to mouth resuscitation between the victim (patient) and the rescuer. This device makes no "guarantee" of disease protection, but it is designed to help protect the rescuer against potentially contaminated secretions and back drafts emanating from the victim while eliminating actual mouth to mouth contact. This device is to be used only by persons trained in CPR and the use of this device. DO NOT USE THIS DEVICE ON INFANTS.
Device Description
The CPRotector 2000 device is a mouth-to-mouth barrier that offers protection to the CPR administrator from vomitus and other oral secretions. It is to be used only by persons trained in the application of CPR. Each CPRotector 2000 comes prepackaged with complete instructions for use. It is labeled as a single-use device and therefore must be disposed of after each use, in accordance with applicable rules and requlations. The CPRotector 2000 includes a one-way valve that directs the breathing gas flow from the CPR administrator to the patient, and directs the exhaled gases away from the rescuer and into the atmosphere. The components used in the manufacture of this device are made from PVC compounds which have been tested to meet the requirements of USP XXII, 1990, and Supplement 5, 1991, for the Biological Test for Plastics, Class VI-70°C.
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K Number
K960615Device Name
GAUZE COMPRESS
Manufacturer
Date Cleared
1996-11-25
(286 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
CERTIFIED SAFETY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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K Number
K960624Device Name
CERTI COOL INSTANT COLD COMPRESS
Manufacturer
Date Cleared
1996-05-06
(83 days)
Product Code
Regulation Number
890.5710Why did this record match?
Applicant Name (Manufacturer) :
CERTIFIED SAFETY MFG., INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces.
Device Description
The Certi*Cool Instant Cold Compress is a self contained disposable unit that provides temporary cold therapy for body surfaces. Each unit is labeled with instructions for use as well as specific warning statements. Our product consists of an inner plastic pouch containing a green-colored water and an outer pouch containing ammonium nitrate. To activate the product, simply rupture the inner pouch by using an external force, such as a fist. Then, as the two ingredients mix, a chemical reaction results by producing temperatures below 40°F for a minimum of 15 minutes. These are single use devices.
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