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510(k) Data Aggregation
K Number
K201460Device Name
Closed System Transfer Device
Manufacturer
Shinva Ande Healthcare Apparatus Co., Ltd.
Date Cleared
2022-11-23
(904 days)
Product Code
ONB
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Shinva Ande Healthcare Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Closed System Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.
Device Description
The Closed System Transfer Device is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Closed System Transfer Device consists of a piston syringe set (Dispensing Connector), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), and Infusion Set.
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K Number
K220057Device Name
Disposable Sterile Syringe with permanently attached needle; Auto-disable Syringe for Fixed-dose Immunization
Manufacturer
Shinva Ande Healthcare Apparatus Co., Ltd.
Date Cleared
2022-10-07
(274 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shinva Ande Healthcare Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Auto-disable Syringe for Fixed-dose Immunization is intended for use in the aspiration and injection of fluids for medical purpose.
Device Description
Not Found
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K Number
K211484Device Name
Disposable Sterile Syringe with Safety Needle; Disposable Sterile Syringe with Needle; Disposable Sterile Syringe; Disposable Safety Needles
Manufacturer
Shinva Ande Healthcare Apparatus Co., Ltd.
Date Cleared
2022-03-01
(293 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shinva Ande Healthcare Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable sterile syringe with safety needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The disposable sterile syringe with needle is intended for use the aspiration of fluids for medical purpose.
The disposable sterile syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.
The disposable safety needles are intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.
Device Description
Not Found
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K Number
K202060Device Name
Disposable IV catheter
Manufacturer
Shinva Ande Healthcare Apparatus Co., Ltd.
Date Cleared
2021-07-23
(361 days)
Product Code
FOZ
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Shinva Ande Healthcare Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable IV catheter is intended to be inserted into a Patient's peripheral vascular system for short term use to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of therapy. The 22-18 GA devices are suitable for use with power injectors set to a maximum pressure of 300 psi when access ports not suitable for use with power injectors are removed.
Device Description
The Safety Straight IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needle stick injury. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, needle hub, vent fitting, safety clip, lid, valve tube, actuator, anti-reflux valve.
Straight IV Catheter System is the same as The Safety Straight IV Catheter System except for the safety device designed to minimize blood exposure.
Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, heparin plug, needleless connector, Luer adapter with dual port.
Closed IV Catheter System is the same as Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
Needleless Safety Closed IV Catheter System is a safety device designed to minimize blood exposure. It includes a passive needle-shielding mechanism designed to reduce accidental needlestick injury. The closed system is designed to keep blood contained within the device throughout the insertion process, which may prevent potential exposure for clinicians and patients. The system consists of the following key parts: protector, needle, catheter hub, wedge, catheter hub wings, septum, needle hub, safety clip, needle shield, extension tubing, pinch clamp, Luer adapter with single port, vent fitting, needleless connector, Luer adapter with dual port.
Needleless Closed IV Catheter System is the same as Needleless Safety Closed IV Catheter System except for the safety device designed to minimize blood exposure. The 18-22 gauge catheter systems are capable of withstanding high pressure injection procedures.
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K Number
K193657Device Name
Disposable Enteral Feeding Syringe with Enfit Connector
Manufacturer
Shinva Ande Healthcare Apparatus Co., Ltd.
Date Cleared
2020-09-12
(257 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Shinva Ande Healthcare Apparatus Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable Enteral Feeding Syringe with Enfit Connector is indicated for use as a dispenser, a measuring device, and a fluid transfer device. It is used to deliver fluids into the gastrointestinal system of a patient who is physically unable to eat and swallow. The enteral feeding syringes are intended to be used in clinical or home care setting by users ranging from laypersons (under the supervision of a clinician) to clinicians, in all age groups.
Device Description
The proposed device is a disposable enteral feeding syringe provided in a variety of size from 1ml-60ml (1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 30ml, 50ml and 60ml). The device is composed by barrel with ENFit connector, piston (plunger and plunger stopper), lubricant and tip cap (with or without). The piston is made of polyisoprene synthetic rubber, without DEHP or natural latex. This device incorporates a female ENFit connector for connection to an enteral access device with a male ENFit connector. They are two types of syringe: Side connector ENFit syringe and central connector ENFit syringe. The size of the central connector ENFit syringes range from 1ml to 5ml, and they are the low dose tip syringes; and side connector ENFit syringes range from 10ml to 60ml, and they are the standard syringes. The Disposable Enteral Feeding Syringe with Enfit Connector relies on the interference matching between piston and inner chamber wall of the barrel to ensure the sealing of liquid in the inner chamber of the barrel. The plunger and the plunger stopper constitute a sealing assembly. By pushing and pulling the plunger, the plunger stopper can be driven to move freely inside the barrel, similar to the piston structure, so as to realize the suction and infusion of fluid. The proposed syringe is sterile. Sterile device was sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf of five years.
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