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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
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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