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510(k) Data Aggregation
K Number
K203613Device Name
ENFit Reusable Enteral Syringe
Manufacturer
Shantou Wealy Medical Instrument Co., Ltd.
Date Cleared
2021-08-27
(260 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Shantou Wealy Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.
Device Description
The proposed device with Enfit® connector (1ml-60ml) are standard piston style syringes consisting of syringe barrel with integral EnFit syringe tip, syringe plunger and ring type piston. The proposed device are supplied non-sterile, and reusable. The sizes rang from 1ml to 60ml nominal capacity. The integral syringe tip is a female ENFit connector which is compatible only with enteral access devices or accessories having ENFit compliant or compatible male connectors to form a dedicated system that prevents wrong-route administration of fluids.
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K Number
K203410Device Name
ENFit Disposable Enteral Syringe
Manufacturer
Shantou Wealy Medical Instrument Co., Ltd.
Date Cleared
2021-06-28
(221 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
Shantou Wealy Medical Instrument Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Wealy ENFit® Disposable Enteral Syringe 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 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 sizes from 1ml~100ml. This device incorporates a female ENFit® connector for connection to an enteral access device with male ENFit® connector. The proposed syringe is 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 life of three years.
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K Number
K141640Device Name
AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE
Manufacturer
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2014-11-19
(153 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Automatically Retractable Safety Syringes with Fixed Needle (Iml, 3ml, 10ml with 30G, 29G, 27G, 26G, 25G, 24G, 23G, 22G, 21G, or 20G) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
Device Description
The Automatically Retractable Safety Syringes with Fixed Needle devices are piston syringes, intended for medical purposes and consist of a calibrated hollow barrel and a movable plunger. The syringe works like a conventional hypodermic syringe except that the contaminated needle is retracted inside the syringe immediately after patient injection. The needle retracting mechanism is activated by a spring action mechanism after injection is completed. The exposed needle remains safely inside the empty syringe barrel for disposal. The Automatically Retractable Safety Syringes with Fixed Needle are sterile, single use, disposable and non-reusable.
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K Number
K113587Device Name
AUTOMATICALLY RETRACTABLE SAFETY SYRINGE (WITH FIXED NEEDLE)
Manufacturer
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
Date Cleared
2012-02-24
(81 days)
Product Code
MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
SHANTOU WEALY MEDICAL INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×1-1/4) is a sterile, single-use, disposable and non-reusable, retractable safety syringe which is intended to provide a safe and reliable method for intramuscular and subcutaneous injection of medication into a patient.
Device Description
The Automatically Retractable Safety Syringe (with fixed needle) 5cc/ml 22×11/4 is a piston syringe. The device is intended for medical purposes and consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into the body. Automatically Retractable Safety Syringe (with fixed needle) (5cc/ml 22×11/4") works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection. Needle retraction is activated by the syringe user. The needle retracting mechanism is activated by a spring action mechanism after injection is completed, while the exposed needle remains safety inside the empty syringe barrel for disposal.
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