Disposable Steriled Infusion Sets with CE &ISO Approvaled

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Model NO.	NEO -105
Material	Plastic
Ethylene Oxide Sterilization	Without Ethylene Oxide Sterilization
Group	Adult
Medical Device Regulatory Type	Type 3
Trademark	IU
Specification	CE certificate and ISO
HS Code	90183900
Type	Infusion Set
Certification	CE, SGS, FDA, ISO13485
Quality Guarantee Period	5 Year
Logo Printing	With Logo Printing
Medical Devices Reg./Record No.	Ssyjxzz-2001-0249
Transport Package	1PC Per Bag, 500PS Per CTN, 800CTN /40hq Container
Origin	Jiangsu, China

Disposable steriled Infusion Sets with CE &ISO approvaled with 21G injection needleneedleeedle
Consist of:
1) Sterilized by EO gas, the product is non pyrogen and non-toxic
2) Material: Polypropylene
3) Application: Used for body vein infusion
4) Big ABS spike and molding plastic drip
5) Thick latex tube
6) luer lock for connecting needles
7) Custom specifications welcomed for completion
Inner packing:
Individual polybag or individual polybag with dialyzer or individual blister bag
Qualifications
1. CE and ISO certificate
2. Stable quality and strict quality control
3. Great production capacity
4. Favourable price
Remark: You can also give us your specific requirements to confirm the products you need finally.

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 .