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510(k) Data Aggregation
K Number
K210464Device Name
Auto Disable Syringe
Manufacturer
Anhui Tiankang Medical Technology Co.,Ltd.
Date Cleared
2021-08-24
(189 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Anhui Tiankang Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AUTO DISABLE SYRINGE is intended for use in the suction of vaccine for medical purposes. Additionally , after injection to the body, the plunger can be automatically locked by the triggered mechanism to prevent the re-use of this syringe.
Device Description
The AUTO DISABLE SYRINGE is designed for the hypodermic injection of the intended micro scale solution. It has the automatic function in the structure of the syringe which after injection of an intended fixed dose locks the syringe to prevent re-use of the syringe. It can be widely used for injection of vaccine for the immunization.
The syringe consists of a calibrated hollow barrel, a movable plunger, a rubber stopper (piston) assembled at end of the plunger, and a steel clip installed between the barrel and the plunger that functions to prevent re-use of the syringe.
At the end of the barrel, a fixed an unmovable needle is installed, and a needle cap covers the needle. The zero line and nominal capacity line are printed outside of barrel. The main materials are PP, latex free (polyisoprene rubber) and stainless steel.
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K Number
K191639Device Name
TK Insulin Syringe with/without Saftey Retractable Device
Manufacturer
Anhui Tiankang Medical Technology Co.,Ltd.
Date Cleared
2020-09-11
(450 days)
Product Code
MEG, FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Anhui Tiankang Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TK Insulin Syringe with Safety Retractable Device is a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The TK Insulin Syringe is a sterile, single-use, disposable, insulin syringe intended for injection of U-100 insulin into the body.
Device Description
The TK Insulin Syringe with/without Safety Retractable Device are similar devices except one has a safety feature and the other is a standard insulin syringe.
The TK Insulin Syringe with/without Safety Retractable Device is an integrated needle and piston syringe with an anti-needle-stick mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn and snapped off which renders the needle unusable and prevents accidental needle sticks. The used syringe is then discarded into a sharp's container.
The subject devices are sterile, single-use, disposable and non-reusable, insulin syringe intended for injection of U-100 insulin into the body.
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K Number
K191640Device Name
TK Intravascular Administration Set
Manufacturer
Anhui Tiankang Medical Technology Co.,Ltd.
Date Cleared
2020-08-26
(434 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
Anhui Tiankang Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TK Intravascular Administration Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.
Device Description
The TK Intravascular Administration Set is a gravity single use device sterilized with Ethylene Oxide gas. It is utilized to administer fluids from a container to a patient's vascular system through a catheter or needle inserted into a vein. The device includes the following components: Protective cap of spike, Spike, Micron filter, Air inlet, Drip chamber, Fluid filter, Tubing, Slide clamp, Pinch clamp, Flow regulator, Roller, Male luer lock, Stopcock (without needleless luer access valve), 4.0mm Connector, Y-site (access by needle), Rotating luer lock, Back check valve, Luer lock cap.
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K Number
K191642Device Name
TK Sterile Piston Syringe without Needle
Manufacturer
Anhui Tiankang Medical Technology Co.,Ltd.
Date Cleared
2020-01-06
(201 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
Anhui Tiankang Medical Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.
Device Description
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip / lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.
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