Dispsoable Medical Infusion Sets with Butterfly Needle (modle YD-I)

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Model NO.	YD-I
Material	Plastic
Ethylene Oxide Sterilization	Ethylene Oxide Sterilization
Group	Adult
Medical Device Regulatory Type	Type 3
Trademark	IU
Specification	CE Certificate and ISO 9001:2000/13485
HS Code	90183900
Type	Infusion Set
Certification	CE, SGS, FDA, ISO13485
Quality Guarantee Period	Two Years
Logo Printing	With Logo Printing
Medical Devices Reg./Record No.	ssyjxzz-2001-024
Transport Package	583838/Cm, 870CTN /40hq
Origin	China

Dispsoable Medical Infusion Sets with butterfly needle
INFUSION SET with two plastic inserters two adjustors
Item No: HB6-08
This is disposable infusion set with two plastic inserters and two adjustors.
Assesoris: Vented spike, dripping champer, roller clamp, solution filter, emulsion tube.
Features:
1) For single use
2) Transparent drip chamber with filter
3) Flexible tubing with standard length of 135cm
4) Thick latex connector
5) Luer lock adapter with hypodermic needle
6) Sterilization: Ethylene-gas-sterilization

Name of Sample		Disposable Infusion Set with needle		Type	IS-VZ 0.7
LOT NO		20130618		Testing Standards	contract requirements
Sterilization Lot		20130618		Quantity of Tested Batch	1260000 pcs
Quantity Of Sample		50pcs		Testing Date	SEP 7, 2013
Type	Testing items		Standard Requirement and Standard Term and Conditions			Actual Testing Result	Conclusion
Biological Properties	Sterility		The infusion set in individual package should be sterile (8.2)			Missing	/
	Pyrogen		Infusion set has no pyrogen (8.3)			Missing	/
Chemical Properties	Reduction Matter		Difference of volumes of potassium permanganate [ c(kmno4 = 0.002mol/L)] consumed by test liquid and blank liquid should be not more than 2.0 ml (7.1)			0.5ml	Eligible
	Ph		The PH difference between testing liquid and blank liquid is not more than 1.5 (7.3)			0.19	Eligible
	Ultraviolet Absorbance		The absorbance of testing liquid should be not more than 0.1 (7.5)			0.046	Eligible
	Ethylene Oxide Residuum		The ethylene oxide residuum should be not more than0.5mg; Unit: mg (7.6)			0.29	/
Physical Properties	Particle Content		For the number of 15-25min particles in 200ml eluent, not more than 1 particle/ml			Eligible	Eligible
			For the number over 25min particles, not more than 0.5 particle/ml (6.1)			Eligible
	Sealing Property		No air leakage of infusion set (6.2)			Eligible	Eligible
	Connection Intensity		Connection of parts for liquid channel of infusion set can bear the static tensile force not less than 15N for 15 seconds. (6.3)			Eligible	Eligible
	Puncture Device Of Bottle Stopper		According to the contract requirements ,Materials for ABS.			Eligible	Eligible
	Liquid Medicine Fitter		The infusion set should be equipped with a liquid machine filter			Eligible	Eligible
			The filtering rate of liquid medicine should be not less than 80%. (6.7)			98.7%
	Flow Speed Of Transfusion (Flow Quantity)		For the infusion set with 20drops/ml, with 1m static press end, the sodium chloride solution flowed should be not less than 1000ml for 10 minutes Unit: ml (6.10)			Eligible	Eligible
	Air Inlet Device (Air Fitter)		The filtering rate against particles 0.5μm in air should be not less than 90%. (6.5.2)5.2)5.2)			Missing	/
	Air Inlet Device (Flow Reduction Rate )		Comparing with vessel with free air input, the flow of effluent should be reduced by 20%. (6.5.5)			Eligible	Eligible
	Packaging requirements		According to the contract requirements			Eligible	Eligible
	Flow Adjustor		Materials for ABS.			Eligible	Eligible
	Soft Pipe (Length)		According to the contract requirements			Eligible	Eligible
	needle		According to the contract requirements			Eligible	Eligible
Testing Results			The seized products meet the requirements of the contract .