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510(k) Data Aggregation
K Number
K090459Device Name
DISPOSABLE TPE INFUSION SET
Manufacturer
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
Date Cleared
2009-10-13
(232 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable TPE Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Device Description
The applicant device is single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of thermoplastic elastomer (TPE) and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel.
The proposed device is provided sterilized.
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K Number
K090012Device Name
DISPOSABLE INFUSION SET
Manufacturer
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
Date Cleared
2009-06-11
(160 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Infusion Set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein.
Device Description
The applicant device is plastic, single-use, sterile disposable infusion device, which is intended to be used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The protective cap is intended to protect the needle; The puncturing needle is made of Polyethylene and used to pierce the container; the catheter is made of Polyvinyl chloride and used to connect various components, there is no DEHP used in the proposed device; the drip is transparent so that the user can observe the dropping condition of the medical solution, and it has a filtration mesh which can prevent the micro particle with diameter larger than 200 um to from entering human vessel; Flow regulator is used to adjust the flow rate from zero to maximum; Infusion needle is inserted into human vessel for medical solution transfusion, it is made of stainless steel. The proposed device is provided sterilized.
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K Number
K083349Device Name
BLOOD TRANSFUSION SET
Manufacturer
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
Date Cleared
2009-04-10
(148 days)
Product Code
BRZ
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Blood Transfusion Set is used to administer blood from a container (plastic bag or glass bottle) to a patient's vascular system through a needle or catheter inserted into a vein.
Device Description
The proposed device is plastic, disposable and sterile blood transfusion set, which is intended to be used to administer the blood from the container to a patient's vascular system through a needle or catheter inserted into a vein via gravity method.
The blood transfusion set consists of protective cap of the closure-piercing device, closure piercing device, tubing, drip, flow regulator, transfusion needle and needle sheath. In addition, there are two kinds of the transfusion set, one has a drug-adding feature and the other hasn't.
There are two specifications of transfusion needle, which are 0.9# transfusion needle and 1.2# transfusion needle.
The proposed device is provided sterilized.
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