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510(k) Data Aggregation
K Number
K223678Device Name
Sterile Syringes for Single Use
Manufacturer
Shanghai Kindly Enterprise Development Group Co., Ltd.
Date Cleared
2023-02-09
(63 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Enterprise Development Group Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sterile Syringes for Single Use are sterile, single-use, disposal, without needle and manually operated syringes intended to use with a 6% conical fitting device for injection of drug into the body. The syringes are intended for use immediately after filling and are not intended to contain the fluid/medication for extended periods of time.
Device Description
KDL Sterile Syringes for Single Use are composed of barrel, plunger, and a moveable piston. The plunger does not contact any part of the fluid path, rather the plunger which attaches to the piston and the barrel are fluid path components. Materials of construction for the components have been shown to meet the applicable requirements of ISO 10993-1. Additionally, there is a small amount of lubricant for moving the plunger smoothly along the inside surface of the barrel. The connector is a universal luer threaded style connector. The device is used in general medicine in clinical, hospital, or other settings of healthcare professionals. The Sterile Syringes for Single Use have different specifications, include 1ml, 3ml, 10ml, 20ml and 30ml.
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K Number
K220185Device Name
Sterile Safety Insulin Syringes for Single Use
Manufacturer
Shanghai Kindly Enterprise Development Group Co., Ltd.
Date Cleared
2022-07-11
(168 days)
Product Code
MEG, FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Shanghai Kindly Enterprise Development Group Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Sterile Safety Insulin Syringes For Single Use are a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U40 or U100 insulin into the body, the sliding sleeve helps protect against needle puncture once activated.
Device Description
KDL Sterile safety insulin syringes have a sliding sleeve which is designed to shield the injection needle to protect the user from needle puncture and the sliding sleeve helps protect against needle puncture once activated. The sliding sleeve can be activated manually.
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