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510(k) Data Aggregation
K Number
K133121Device Name
CHITO-SAM 100,4IN X4IN,CHITO-SAM, 3IN X6FT, CHITO-SAM 100,3IN X10FT, CHITO-SAM ACTIVE, 4INX4IN,CHITO-SAM ACTIVE, 3INX6FT
Manufacturer
SAM MEDICAL PRODUCTS
Date Cleared
2014-05-22
(234 days)
Product Code
QSY, FRO
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SAM MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Chito-SAM™ Active (over-the-counter use):
To control bleeding of lacerations, minor cuts and abrasions.
Chito-SAM™ 100 (prescription use):
For use as a temporary external dressing to control moderate to severe bleeding and manage external abrasions and lacerations.
Device Description
The Chito-SAM" Gauze (refers to both the Chito-SAM" 100 for prescription use and Chito-SAM" Active for over-the-counter use) is made of a non-woven fabric derived from chitosan fibers. Chitosan is a naturally occurring polysaccharide usually derived from shellfish, and its hemostatic properties are widely recognized in the biomedical field. When applied directly on a wound with firm pressure, the Chito-SAM Gauze will turn into a gel-like condition to absorb the blood and assist in temporarily controlling moderate to severe bleeding. The Chito-SAM Gauze is provided in three (3) different sizes for prescription use and two (2) different sizes for over-the-counter use to accommodate a variety of treatment regions. The Chito-SAM Gauze is individually packaged in a foil pouch and is gamma-sterilized.
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K Number
K131561Device Name
SAM JUNCTIONAL TOURNIQUET
Manufacturer
SAM MEDICAL PRODUCTS
Date Cleared
2013-07-24
(55 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
SAM MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:
- . To control difficult bleeds in the inguinal area.
- . To control difficult bleeds in the axilla area.
- To immobilize a pelvic fracture. .
Device Description
The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage and axilla hemorrhage. The device is designed to control bleeding in the inguinal area or axilla area where standard tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.
A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable Target Compression Device (TCD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.
The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.
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K Number
K123694Device Name
SAM JUNCTIONAL TOURNIQUET
Manufacturer
SAM MEDICAL PRODUCTS
Date Cleared
2013-03-07
(94 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
SAM MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:
- To control difficult bleeds in the inguinal area. .
- To immobilize a pelvic fracture. .
Device Description
The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage. The device is designed to control bleeding in the inguinal area where standard Tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.
A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable point pressure device (PPD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.
The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.
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K Number
K102403Device Name
SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
Manufacturer
SAM MEDICAL PRODUCTS
Date Cleared
2011-03-03
(191 days)
Product Code
NAD
Regulation Number
878.4020Why did this record match?
Applicant Name (Manufacturer) :
SAM MEDICAL PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used as an occlusive wound dressing. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds, and to be used in emergency situations and to be left in place only while the patient is transported to the hospital.
Device Description
SAM Chest Seal with Valve: The SAM Chest Seal with valve is an adhesive dressing composed of a hydrogel based adhesive with a clear backing and check valve. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound. The one way valve prevents air pressure from increasing in the pleural space.
SAM Chest Seal: The SAM Chest Seal is an adhesive dressing composed of a hydrogel based adhesive with a clear backing. The chest seal is placed over the open chest wound. The skin adhesive holds it in place over the wound.
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