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510(k) Data Aggregation
K Number
K161979Device Name
ENFit enteral syringe
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD.
Date Cleared
2017-03-22
(247 days)
Product Code
PNR
Regulation Number
876.5980Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed device 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~60ml. This device incorporates a female ENFit connection to an enteral access device with male ENFit connector.
The propsoed 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 five years.
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K Number
K152323Device Name
Disposable Infusion Needle, Safelock Disposable Infusion Needle
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD
Date Cleared
2015-12-14
(119 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient' s vascular system through the needle inserted into the vein.
Safelock Disposable Infusion Needle is intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein, and the safety sheath is designed to prevent accidental needlesticks.
Device Description
The proposed devices are intended to administer fluid by using an infusion set to a patient's vascular system through the needle inserted into the vein. The device contains a conical fitting provides a standard female luer lock connector which may connect to an I.V. administration set with a male conical fitting. And the infusion needle is inserted patient's vein. Then the solution will be administered from the I.V. administration set through the infusion needle into patient vascular by gravity.
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K Number
K151991Device Name
Safelock Disposable Blood Collection Set, Disposable Blood Collection Set
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD.
Date Cleared
2015-12-11
(144 days)
Product Code
FPA
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients.
The Safelock disposable blood collection sets are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients, and the safety sheath is designed to aid in the reduction of accidental needlesticks.
Device Description
The proposed devices are provided sterile, single use. The proposed devices are intended to be used with vacuum blood collection tube for venipuncture to collect blood specimens from patients. It has two models, Safelock disposable blood collection set and Disposable blood collection set.
For disposable blood collection set, they consist nine pieces components: (1) needle protect cover (2) patient-end tube needle (3) double wing needle handle (4)flexing tube (5) connect A (6) non-patient needle hub (7) puncture needle (8) rubber sleeve (9) puncture needle protective cover.
For Safelock disposable blood collection sets, they consist twelve components: (1) needle protect cover (2) patient-end tube needle (3) safety needle handle (4) double wing (5) safety sheath (6) Locking joint (7) flexing tube (8) connect A (9) non-patient needle hub(10) puncture needle (11) rubber sleeve (12) puncture needle protect cover.
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K Number
K151949Device Name
Disposable Insulin Syringe
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD.
Date Cleared
2015-10-02
(79 days)
Product Code
FMF
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable insulin syringe is intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
Device Description
The Disposable Insulin Syringes are provided sterile, single use.
For the Disposable Insulin Syringes, they consist of six components: (1) orange needle cap (2) needle (3) piston (4) plunger (5) barrel (6) orange protective end cap. The materials for all components are listed in Table 1 Component material list.
The Disposable Insulin Syringes are available in different combination of syringe volumes and needle sizes. The range of syringe volume, needle gauge and needle length are listed in Table 2 syringe and needle specification.
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K Number
K150758Device Name
Safety Disposable Insulin Syringe
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD
Date Cleared
2015-06-18
(87 days)
Product Code
FMF, MEG
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.
Device Description
Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.
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K Number
K141359Device Name
HARD PACK SYRINGE
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD
Date Cleared
2014-07-25
(63 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body. Needles are intended to be used with a legally marketed syringe intended to inject fluids into or withdraw fluids from the body.
Device Description
The proposed devices contain syringes and needles with various models. All the models for syringes and needles follow same design principle respectively; the differences are the size of the devices. The proposed devices are intended to inject fluids into or withdraw fluids from the body. The proposed devices would be available in two different configurations: Syringe with needle and Syringe without needle. Proposed devices are provided radiation (Co60) sterilized with a hard pack package which could maintain the sterility of the devices for five years. They are for single use only.
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K Number
K113091Device Name
SYRINGES AND NEEDLES
Manufacturer
JIANGYIN CAINA TECHNOLOGY CO., LTD
Date Cleared
2011-10-28
(9 days)
Product Code
FMF, FMI
Regulation Number
880.5860Why did this record match?
Applicant Name (Manufacturer) :
JIANGYIN CAINA TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Syringes with or without needle are intended to inject fluids into or withdraw fluids from the body.
Needles are intended to be used with a legally marketed syringe intend to inject fluids into or withdraw fluids from the body.
Device Description
The proposed devices include: a standard piston syringes consisting of the proposed syringes consist of three components: (1) barrel, (2) piston and (3) plunger rod, and a needle consists of (1) needle tube, (2) needle hub and (3) needle sheath. They would be available in three different configurations respectively as follows:
Configuration 1 Syringes with Needle
Proposed syringes will be provided along with a proposed needle in one single package. The combinations of sizes are various upon the request of the users.
Configuration 2 Syringes without Needle
Proposed syringes will be provided without a needle. The combination of sizes are various upon the It could be used together with any other U.S. legally marketed request of the users. a) hypodermic needle with luer slip female connector complied with ISO594-1:1988 or 'iver lock female connector complied with ISO 594-2:1996.
Configuration 3 Needles
Proposed needles will be provided alone, which could be used together with any other U.S. legally marketed syringes with luer slip male connector complied with ISO594-1:1988 or luer lock male connector complied with ISO 594-2:1996 to complete its intended use.
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