SHANDONG ZIBO SHANCHUAN MEDICAL INSTRUMENT...

SHANDONG ZIBO SHANCHUAN MEDICAL INSTRUMENT CO., LTD MADE BY MARTIN CHEN [email protected] 0086-13581009626

BRIEF INTRODUCE FDA CE ISO9002 SHANDONG ZIBO SHANCHUAN MEDICAL INSTRUMENT CO., LTD. has been a leading manufacturer and exporter in the line of disposable medical devices for 15 years in China. The company has about 5000 workers and the production equipment is over 360 sets. Covers an area of 40 hectares and has 35000 square meters purified workshops which are up to national standard. An international standard quality control

system has been set up in the company. The company has obtained ISO9002 Quality Control System Certificate by China Quality Certificate Center for Import & Export Commodities and obtained CE Certificate by TUV Product Service German, and we have obtained American FDA certificate (510K NUMBER: K021993, REGULATION NUMBER: 8805860,8805570). Our products are sold well in domestic and overseas markets; over 80% products are exported to more than 100 countries and religions. More than 15 kinds and 100 specifications medical devices can be produced in our company. 800,000 syringe sets, 500,000 infusion sets, 200,000 blood transfusions, 500,000 scalp vein

sets, 1,000,000 hypodermic needles, 4,000 disposable obstetrical kits. 20,000 luxury urine bags, 2,000 vagina speculum and 50,000 infusion liquid bags can be produced per day. Payment terms and conditions: T/T in advance or confirmed L/C at sight. . We can ship the goods within 30 days after receiving the deposit or original L/C.


FDA 510K K021993

OUR FACTORY HAS OBTAINED FDA510K K021993 CERTIFICATE.

LIST NUMBER: 9047402

REGISTER No: 9710508

NOTICE:

may be you can look over .PDF document from the FDA web below:

http://www.fda.gov/cdrh/pdf2/k021993.pdf

if it can be read, please first to download the adobe reader software from the web below.:

http://www.adobe.com/products/acrobat/readstep2.html

ISO9002

ISO9002 FOR DISPOSABLE SYRISNG SET, HYPODERMIC NEEDLE, SCALP VEIN SET, INFUSION

SET, BLOOD TRANSFUSION SET, URINE BAG2000ML


CE0123 TUV certificates


SYRINGE FOR SINGLE USE ONLY

Three-parts disposable syringe set

Three-parts disposable syringe set Parts, 1ml, 2ml, 2.5ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml,

the types have luer slip and luer lock.

All sizes can be with needle.

A. Registration Certificate of Disposable Syringe Set

1. Producing License (No.: XK24-138 0007)

2.Hygiene License (No.: 3? 85/95)

3.License no Manufacturing Measure Appliance (No.: 03020101/97)

4. Certificate of ISO9002 & EN46002 issued by TUV (No.: Q2 Z 02 01 34827 005)

5. Certificate of CE Issued by TUV (No.: G2 04 03 34827 006)

B. Type and Chemical Composition of Raw Materials

Name of Parts Name of Code of Raw Material

1. Safety Cover Polypropylene P.P. HT-022

2. Cannula Stainless Steel 1Cr18Ni9Ti

3. Hub Polypropylene P.P. HT-022

4. Plunger Polypropylene P.P. HT-022

5. Barrel Polypropylene P.P. HT-022

6. Piston Natural Rubber for Medical


Two-parts disposable syringe set

Luer slip,

the sizes: 2ml/cc, 5ml/cc, 10ml/cc, 20ml/cc

A. Registration Certificate of Disposable Syringe Set

1. Producing License (No.: XK24-138 0007)

2.Hygiene License (No.: 3? 85/95)

3.License no Manufacturing Measure Appliance (No.: 03020101/97)

4. Certificate of ISO9002 & EN46002 issued by TUV (No.: Q2 Z 02 01

34827 005)

5. Certificate of CE Issued by TUV (No.: G2 04 03 34827 006)

B. Type and Chemical Composition of Raw Materials

Name of Parts Name of Code of Raw Material

1. Safety Cover Polypropylene P.P. HT-022

2. Cannula Stainless Steel 1Cr18Ni9Ti

3. Hub Polypropylene P.P. HT-022

4. Plunger Polypropylene P.P. HT-022

5. Barrel Polypropylene P.P. HT-022


Disposable syringe catheters tip

25PCS/BOX, BOX MEAS: 21.5X15X20.5CM.

200PCS/CTNS, CTNS MEAS: 45X33X44CM.

455CTNS/20FT. (91000PCS)

1. Carton: Double-layer corrugated carton

a. Outer Surface: 300g Kraft

b. Middle: 127g High Strength Corrugated Paper

c. Inner Surface: 300g Kraft

d. Printings on Carton:

2. Inner Box: 350g White Paperboard (See inner box)

3. Individual Packing: Double-layer Plastic Bag (PE+OPP film)

Remarks: Printings including carton, secondary package & primary package could

be printed as the clients requested.


SYRINGE WITH BLISTER PACKAGE


INFUSION SET FOR SINGLE USE ONLY

IV-4-1: ABS three holes flange piercing device with cap, mould plastic chamber, PVC

tube 1500mm, PP flow regulator, latex tube, PVC luer lock or luer slip fitting,

hypodermic needle 21Gx1 1/2? 0.8x38mm, 19G air-way needle.

25pcs/bag, 500pcs/ctns, carton meas: 58x38x38cm, 360CTNS/20FT.


I.V.-5-1:ABS vented spike with cap, air inlet with air filter and closure, larger mould plastics chamber, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle, 21Gx11/2”0.8x38mm. I.V.-5-2:ABS vented spike with cap, mould plastics chamber (middle type), PVC tube 1350-1500mm, PP flow regulator, latex flash ball, and luer lock or luer slip fitting, hypodermic needle21Gx11/2 “0.8x38mm I.V.-5-3: ABS vented spike with cap, 19GX20mm limit to flow needle 1ml=60drops use for Pediatrics, larger mould plastics chamber, PVC tube 1350-1500mm, PP flow regulator, latex Flash ball, luer lock or luer slip fitting, hypodermic needle 23Gx1” or 25Gx3/4”. I.V.-5-4:ABS vented spike with cap, smaller mould plastics chamber, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 21Gx11/2”0.8x38mm.


I.V.-6-1:ABS vented spike with cap, larger mould plastics chamber with disk filter, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 21Gx11/2”0.8x38mm.

I.V.-6-2:ABS vented spike with cap, smaller mould plastics chamber with disk filter, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 21Gx11/2”0.8x38mm.


I.V.-6-3:ABS Steel spike with cap, short tube, ABS cap, mould plastics chamber with disk filter, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 21Gx11/2”0.8x38mm, special air-way needle. I.V.-6-4:ABS vented spike with cap, mould plastics chamber (middle type) with disk filter, PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 21Gx11/2”0.8x38mm.

IV-6-5: ABS vented spike with cap and without air vent, small mould plastics

chamber with disk filter, PVC tube 1500mm, PP flow regulator, rubber cone, luer lock

fitting, hypodermic needle 21Gx1 1/2? 0.8x38mm.


IV-6-6: ABS vented spike with cap, lager mould plastics chamber, PVC tube

1350-1500mm, ABS flow regulator, latex flash ball, luer lock or luer slip fitting,

hypodermic needle 21Gx1 1/2? 0.8x38mm

IV-8-1: ABS vented spike with cap, lager mould plastics chamber with air filter, PVC

tube 1350-1500mm, ABS flow regulator, latex flash ball, luer lock or luer slip fitting,

hypodermic needle 21Gx1 1/2? 0.8x38mm.


IV-8-2: ABS vented spike with cap, lager mould plastics chamber, PVC tube

1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting,

hypodermic needle 21Gx1 1/2? 0.8x38mm.

Infusion set with

burettes is special

used for the children.

There are graduate

scales on the burette so

that we could control

the dose and speed of

the solution accurately


PRECISION INFUSION SET

is new generation infusion sets used for human vein infusion. We have two

specifications: 3um and 5um .it takes advantage in filter particles in the infusion

solution more effectively


Photophobic infusion sets

Are used for vein infusion, suitable for the medicines, which are easy to be chemical

changed. It is the best infusion set to guarantee the effective composition will not

change and enhance clinical treatment.

INFUSION SET WITH FLOW METER


<ß INFUSION SET WITH FLOW METER BLISTER PACKAGE

INFUSION SET IN BULK WITHOUT NEEDLE


IS-NV-C

IS-NV-C-1

IS-V-BD


IS-V-BD FLEXIBILITY TUBE管

IS-V-BD

IS-V-BD-1


BLOOD TRANSFUSION SET FOR SINGLE USE ONLY.

BT-1: ABS wing spike with cap, double chamber with tongue sharp filter, PVC tube

1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting,

hypodermic needle 18Gx1 1/2? 1.2x38mm, air-way needle.


B.T.-3: ABS vented spike with needle, large single mould plastics chamber with trestle filter PVC tube 1350-1500mm, PP flow regulator, latex flash ball, luer lock or luer slip fitting, hypodermic needle 18Gx11/21.2x38mm


Butterfly Needle, 18G-27G,Needle Length 20mm, PVC Tube 300mm, Luer Lock Or Luer Slip Fitting, Poly-Bag Or Blister Packing.

NEW INDUSTRY PARK

SHANDONG ZIBO SHANCHUAN MEDICAL INSTRUMENT CO., LTD ADDRESS: CHENGNAN TOWN ZICHUAN ZIBO CITY SHANDONG PROVICE CHINA ZIP: 255100 TEL: 0086-533-2557777 FAX: 0086-533-2557777 CELL: 0086-13581009626 LINKMAN: MARTIN CHEN EMAIL: [email protected] WEBSITE: www.medical-chinese.com/

SHANDONG ZIBO SHANCHUAN MEDICAL INSTRUMENT...

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