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Quality Reliability Excellence

SUNDER BIOMEDICAL TECH. CO., LTD.


Sunder Biomedical was founded with the mission to deliver the best in the concern of humanity and technology. Sunder Biomedical is committed to conduct its business activities in compliance with local laws and regulations that apply to our business. Excellent workmanship , timely delivery and eďŹƒcient service are integrated components of our quality system. All our products are manufactured in class-10,000 clean rooms.

EC REP

SUNDER GROUP

http://www.sunder.com.tw

Well Kang Ltd (www.well-kang.com)

The Black Church,St.Mary's Place,Dublin7,Ireland

Establishment : 16th July 1998 Taiwan Employees : 200 people Worldwide Employees : ~ 340 people

SUNDER headquarter is in Taichung, Taiwan. We have set one overseas oďŹƒce in Singapore, three factories worldwide locating in Taiwan, China, and Thailand; and one medical grade PVC compound factory in Taiwan.

China Tianjin (Factory)

Taichung (Headquarter) Changhua (Factory) Yunlin (Factory)

Taiwan

Singapore (Office)

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BLOOD LINE SET FOR HEMODIALYSIS Sunder produces high quality Blood Line Sets for all your dialysis needs, fitting all types of dialyzers and dialysis equipments.

Features Medical grade PVC tubing ETO sterilization 100% test for each blood line set Guarded access ports reduce infection risks Superior quality, unique design and high performance Material Options : DEHP PVC COMPOUND & DEHP-FREE PVC COMPOUND Male/Female Luer locks in compliance with international standards & regulations

Each manfucturing step is strictly controlled from plastic formulation to final sterilization.

DEHP Free / Non-P

ETO Sterilization

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ETO STERILIZATION General specification: Pump Segment

Main Tube

Inside and outside Diameters (mm)

Inside and outside Diameters (mm)

"S" Series

6.4 x 9.8

4.4 x 6.6

SI-00602

"G" Series

8 x 12

4.4 x 6.6

SI-00602 SI-00607

"K" Series

6.4 x 9.8

4.4 x 6.6

SI-00604

All customized bloodlines are available on request. OEM & ODM are available on request.

Drip Chamber Code

PRODUCTS

Model

Drawing of Standard Type:

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A.V. FISTULA NEEDLE SET Made by Needle Assembly Machines guarantee no damage to the needle tip during the assembly process. Rotating or ďŹ xed wing, every type is available, made by medical polymer materials, sterilized by ETO gas. Sterile, non-toxic, pyrogen free.

Features

TYPE NO.

Wing type

SD-A15G-1 SD-A15G-2 SD-A15G-3 SD-A15G-4 SD-A15G-5 SD-A15G-6 SD-A16G-1 SD-A16G-2 SD-A16G-3 SD-A16G-4 SD-A16G-5 SD-A16G-6 SD-A17G-1 SD-A17G-2 SD-A17G-3 SD-A17G-4 SD-A17G-5 SD-A17G-6

Fixed Fixed Fixed Rotating Rotating Rotating Fixed Fixed Fixed Rotating Rotating Rotating Fixed Fixed Fixed Rotating Rotating Rotating

Package

diameter Needle length Wing color Needle(mm) (inch) Blue Blue Blue Blue Blue Blue Green Green Green Green Green Green Orange Orange Orange Orange Orange Orange

1.8 1.8 1.8 1.8 1.8 1.8 1.6 1.6 1.6 1.6 1.6 1.6 1.4 1.4 1.4 1.4 1.4 1.4

Tube length

1" 1.1/2" 1.1/4" 1" 1.1/2" 1.1/4" 1" 1.1/2" 1.1/4" 1" 1.1/2" 1.1/4" 1" 1.1/2" 1.1/4" 1" 1.1/2" 1.1/4"

(cm)

30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30 30

PRODUCTS

Unique process on blade to reduce pain Unique process on blade to reduce skin damage Ultra wall and siliconized fistula needle with or without back eye Flexible fixed or rotating wing for easy slip-free puncture operation Clear kink resistant tube fitted with Female Luer lock & pinch clamp

Method 1: 1 set/1 pouch,200 sets/1 inner box, 5 boxes/1 export carton/4.8' Method 2: 1 set/1 pouch,150 sets/1 inner box, 4 boxes/1 export carton/3.6'

SAFETY GUARD (Option) Safe, easy to use and effective, our A.V.F. needle sets don't require extra part.

1 2 3

Withdraw needle, the cannula will drop down along the protector slot. Push into the slot hole slightly, then the cannula won't come off. Difference between normal pinch clamp and innovated safety clamp.

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BLOOD LINE SET CUSTOM MADE COMPONENTS & ACCESSORIES All bloodline set components and accessories are available. REVOLVING LUER LOCK CONNECTORS

INJECTION SITES

Luer lock connector Code No. : SI-00401 Material : PVC For O.D. 3.6mm tube Color : Blue

PC-LT ( I ) Code No. : SI-00101 Material : PVC For O.D. 6.6mm tube Color : Transparent

T-Injection Site Code No. : SI-00301 Material : PVC For O.D. 6.6mm tube Color : Blue

Luer lock connector Code No. : SI-00402 Material : PVC For O.D. 3.6mm tube Color : Red

PC-LT ( II ) Code No. : SI-00102 Material : PVC For O.D. 6.6mm tube Color : Transparent

T-Injection Site Code No. : SI-00302 Material : PVC For O.D. 6.6mm tube Color : Red

Luer lock connector Code No. : SI-00403 Material : PVC For O.D. 2.4mm tube Color : Red

PC-LT ( VII ) Code No. : SI-00106 Material : PVC For O.D. 6.8mm tube Color : Transparent

T-Injection Site Code No. : SA-00110 Material : PVC For O.D. 6.6mm tube Color : Blue

Luer lock connector Code No. : SI-00404 Material : PVC For O.D. 1.9mm tube Color : Red Luer lock connector Code No. : SI-00406 Material : PVC For O.D. 4.8mm tube Color : Transparent Luer lock connector Code No. : SI-00416 Material : PVC For O.D. 5.5mm tube Color : Transparent Luer lock connector Code No. : SI-00417 Material : PVC For O.D. 5.5mm tube Color : Transparent Luer lock connector Code No. : SI-00418 Material : PVC For O.D. 5.5mm tube Color : Transparent Luer lock connector Code No. : PI-00160 Material : PVC For O.D. 4.1mm tube Color : Transparent

LOCK RING LOCK ( I ) Code No. : SI-00201 Material : PP Color : Blue LOCK ( I ) Code No. : SI-00202 Material : PP Color : Red LOCK ( II ) Code No. : SI-00203 Material : PP Color : Blue LOCK ( II ) Code No. : SI-00204 Material : PP Color : Red

LUER LOCK CONNECTORS WITH LOCK RING

T-Injection Site Code No. : SA-00111 Material : PVC For O.D. 6.6mm tube Color : Red T-Injection Site (with silicon plug) Code No. : SI-00313 Material : PVC For O.D. 6.8mm tube Color : Blue T-Injection Site (with silicon plug) Code No. : SI-00314 Material : PVC For O.D. 6.8mm tube Color : Red

PRIMING CONNECTORS Recirculating luer lock Code No. : SI-01302 Material : PP Luer lock priming Color : White

COMPONENTS

FEMALE LUER LOCK

Recirculating luer lock adaptor Code No. : SI-01305 Material : PP Luer lock priming Color : White

Revolving Luer lock Connectors, Lock Ring, Injection Sites, F female Luer lock, Clamps, Drip Chambers, Top Caps, Caps, Dialyzer Connectors, Pump Connectors, Filters, Priming Connectors, Roller Clamp, Rubber Bottom, Transducer Protector, Spike, Pillow, etc.

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CLAMPS Clamp- L Code No. : SI-00514 Material : PP Big clamp Color : Blue Clamp-L Code No. : SI-00515 Material : PP Big Clamp Color : Red Clamp- L Code No. : SI-00517 Material : PP Big clamp Color : White Clamp-S Code No. : SI-00526 Material : PP Small Clamp Color : Blue Clamp-S Code No. : SI-00527 Material : PP Small Clamp Color : Red Clamp-S Code No. : SI-00525 Material : PP Small Clamp Color : White

SPIKE Spike Code No. : SA-00109(Spike set) SI-01512(Spike) L=54mm Material : ABS For O.D. 5.5mmx2 tube Color : White Spike(ll) Code No. : PA-00021(Spike set) PI-00449(Spike) L=65.6mm Material : ABS Female Luer Connector Spike Color : White Spike(lll) Code No. : PA-00023(Spike set) PI-01122(Spike) L=65.6mm Material : ABS For O.D. 4.1mm tube Color : White

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DRIP CHAMBERS

DRIP CHAMBERS

Drip chamber Code No. : SI-00602 Material : PVC / Shore A 86-88 Top side O.D. 24.6mm L=122.3mm For O.D. 6.6mm tube Total volume =25ml Color : Transparent Filter : SI-01201

Drip chamber Code No. : SI-00618 Material : PVC / Shore A 86-88 Top side O.D. 24.6mm L=122.0mm For O.D. 6.6mm tube Total volume =25ml Color : Transparent Filter : SI-01201

Drip chamber Code No. : SI-00604 Material : PVC / Shore A 86-88 Top side O.D. 20.6mm L=116.6mm For O.D. 6.6mm tube Total volume =20ml Color : Transparent Filter : SI-01202

Drip chamber Code No. : SI-00620 Material : PVC Top side O.D. 24.6mm L=117.3mm For O.D. 6.6mm tube Total volume =20ml Color : Transparent Filter : SI-01206

Drip chamber Code No. : SI-00607 Material : PVC / Shore A 86-88 Top side O.D. 30.4mm L=124mm For O.D. 6.6mm tube Total volume =22ml Color : Transparent Filter : SI-01201

Drip chamber (II) Code No. : SA-00129 Material : PVC Top side O.D. 30.4mm L=120mm For O.D. 6.8mm tube Total volume =20ml Color : Transparent

Drip chamber Code No. : SI-00613 Material : PVC / Shore A 86-88 Top side O.D. 30.6mm L=128.0mm For O.D. 6.6mm tube Total volume =68ml Color : Transparent Filter : SI-01202

Drip chamber Code No. : PI-00443 Material : PVC For O.D. 4.1mm tube Color : Transparent

CAPS Drip chamber Code No. : SI-00614 Material : PVC / Shore A 79-81 Top side O.D. 24.6mm L=122.3mm For O.D. 6.6mm tube Total volume =25ml Color : Transparent Filter : SI-01202

Cap for female lock Code No. : SI-00801 Material : PP/PE Color : Transparent Cap for dialyzer adaptor Code No. : SI-00903 Material : PP/PE Color : Transparent


TOP CAPS

Cover for drip chamber Code No. : SI-00705 Material : PVC Three-lead top cap For 6.6,3.6,3.6mm Tubes Drip chamber O.D. 24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00737 Material : PVC Two-lead top cap For 6.6,3.6mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00706 Material : PVC Two-lead top cap For 6.6,3.6mm Tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00738 Material : PVC Three-lead top cap For 6.6,5.5,5.5mm tubes Drip chamber O.D.30.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00710 Material : PVC Three-lead top cap For 6.6,3.6,3.6mm tubes Drip chamber O.D.20.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00739 Material : PVC Three-lead top cap For 6.6,4.1,4.1mm tubes Drip chamber O.D.30.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00711 Material : PVC Two- lead top cap For 6.6,3.6mm tubes Drip chamber O.D.20.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00741 Material : PVC Three-lead top cap For 6.6,5.5,5.5mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00713 Material : PVC Three-lead top cap For 6.6,3.6,3.6mm tubes Drip chamber O.D.30.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00742 Material : PVC Two-lead top cap For 6.6,6.6mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00728 Material : PVC Three-lead top cap For 6.6,3.6,5.5mm tubes Drip chamber O.D.30.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00743 Material : PVC Three-lead top cap For 6.6,5.5,4.1mm tubes Drip chamber O.D.30.0mm Color : Transparent

Cover for drip chamber Code No. : SI-00735 Material : PVC Three-lead top cap For 6.6,3.6,3.6mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00744 Material : PVC Two-lead top cap For 6.6,4.1mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00736 Material : PVC Three-lead top cap For 6.6,3.6,5.5mm tubes Drip chamber O.D.24.6mm Color : Transparent

Cover for drip chamber Code No. : SI-00745 Material : PVC Three-lead top cap For 6.6,4.1,3.6mm tubes Drip chamber O.D.24.6mm Color : Transparent

TOP CAPS Cover for drip chamber Code No. : SI-00751 Material : PVC Two-lead top cap For 6.6,3.6mm tubes Drip chamber O.D.24.6mm Color : Transparent

DIALYZER CONNECTORS Dialyzer adaptor Code No. : SI-01011 Material : PVC(soft) For 6.6mm tube Color : Blue Dialyzer adaptor Code No. : SI-01012 Material : PVC(soft) For 6.6mm tube Color : Red Dialyzer adaptor Code No. : SI-01013 Material : PVC(rigid) For 6.6mm tube Color : Blue Dialyzer adaptor Code No. : SI-01014 Material : PVC(rigid) For 6.6mm tube Color : Red Dialyzer adaptor Code No. : SI-01015 Material : PVC For 6.6mm tube Color : Blue Dialyzer adaptor Code No. : SI-01016 Material : PVC For 6.6mm tube Color : Red

FILTERS

COMPONENTS

TOP CAPS

Filter-L Code No. : SI-01201 Material : PP Dimension : 16.2 mm Color : Transparent ( Filter mesh -270um ) Filter-S Code No. : SI-01202 Material : PP Dimension : 14.5 mm Color : Transparent ( Filter mesh -270um ) Filter-S Code No. : SI-01206 Material : PP Dimension : 14.5 mm Color : Transparent ( Filter mesh -270um ) 9


PUMP CONNECTORS Pump segment connector Code No. : SI- 01101 Material : PVC For O.D. 9.8mm Pump Segment With 3.6mm tube Color : Transparent Pump segment connector Code No. : SI- 01102 Material : PVC For O.D. 9.8mm Pump Segment With 2.4mm tube Color : Transparent Pump segment connector Code No. : SI-01103 Material : PVC For O.D. 12mm Pump Segment With 3.6mm tube Color : Transparent Pump segment connector Code No. : SI-01104 Material : PVC For O.D. 12mm Pump Segment With 2.4mm tube Color : Transparent Pump segment connector Code No. : SI-01105 Material : PVC For O.D. 12mm Pump Segment Color : Transparent Pump segment connector Code No. : SI- 01106 Material : PVC For O.D. 9.8mm Pump Segment With 5.5mm tube Color : Transparent Pump segment connector Code No. : SI- 01107 Material : PVC For O.D. 12mm Pump Segment With 4.1mm tube Color : Transparent Pump segment connector Code No. : SI-01108 Material : PVC For O.D. 9.8mm Pump Segment With 2.4mm tube Color : Transparent Pump segment connector Code No. : SI-01109 Material : PVC For O.D. 9.8mm Pump Segment Color : Transparent Pump segment connector Code No. : SI-01110 Material : PVC For O.D. 9.8mm Pump Segment With 4.1mm tube Color : Transparent

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Male Luer

TRANSDUCER PROTECTOR

Male luer lock cap Code No. : PI-00447 Material : PP Color : Transparent

Code No. : PA-00010 Material : PVC Male-female luer lock Color : Transparent

Male luer connector Code No. : PI-00448 Material : ABS Color : White

Code No. : SA-00097 Material : PVC For tube O.D. 5.5mm Color : Transparent

RUBBER BOTTOM Code No. : PO-00010 Material : Silicon Color : Nature

A-WU CLAMP Code No. : PI-00387 Material : POM (Poluformaldehyde) Color : Blue Code No. : PI-00388 Material : POM (Poluformaldehyde) Color : Red Code No. : PI-00240 Material : POM (Poluformaldehyde) Color : White

BUTTER-FLY NEEDLE SET Code No. : PA-00367 (15G x 1”) PA-00370 (15G x 1”1/4) Material : PVC For 5.0mm tubes Color : Blue Code No. : PA-00368 (16G x 1”) PA-00371 (16G x 1”1/4) Material : PVC For 5.0mm tubes Color : Green Code No. : PA-00369 (17G x 1”) PA-00372 (17G x 1”1/4) Material : PVC For 5.0mm tubes Color : Orange

Code No. : PA-00025 Material : PVC For tube O.D. 5.5mm Color : Transparent

ROLLER CLAMP Code No. : PI-00040 Material : ABS For 4.1mm tube Color : White

THREE WAY CONNECTOR Code No. : PI-00170 Material : PVC For 6.6,4.1mm tubes Color : Transparent

PILLOW Code No. : SA-00010 Material : PVC For O.D. 6.6mm tube Color : Transparent Code No. : SA-00125 Material : PVC Color : Transparent For O.D. 6.6mm tube Service Line Connector for O.D. 5.5mm tube Color : Transparent Code No. : SA-00130 Material : PVC Color : Transparent For O.D. 6.6mm tube Service Line Connector for O.D. 4.1mm tube Color : Transparent


PVC COMPOUNDS FOR MEDICAL APPLICATIONS Sunder has developed PVC compounds since 2002. Sterilization by ETO and Steam (Gamma-ray in development) Certification USP, JP with EN-71 part 3 (heavy metal inspection) Development PVC compounds using non-phthalate plasticizers

1. Biocompatibility test (Class VI Test-USP, 21CFR, Part 58 GMP for NonClinical Laboratory Studies) (1) Systemic Injection Test (2) Intracutaneous Injection (3) Implant Test

2. Extractable substance tests (JPXIV) : (1) Appearance (2) Foaming test (3) pH (4) Potassium permanganate reducing substances (5) Residue on evaporation (6) Absorption test (7) Tin, Pb (i.e.Ch.P.VI)

3. Heavy metals (EN-71 Part 3) Lead (Pb) Barium (Ba) Cadmium (Cd) Antimony (Sb) Mercury (Hg) Arsenic (As)

PVC

Chromium (Cr)

Selenium (Se) Detection limits : 0.25-1.5 ppm

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OVERALL SPECIFICATIONS & APPLICATIONS Sunder's medical grade PVC compounds can be sterilized by both ETO and steam. For compliance with healthcare and environmental protection requirements, Sunder's products are certiďŹ ed by USP, JP for safety assurance and with EN-71 part 3 for free-from-heavy metal inspection.

Specifications

Clear extrusion

Clear injection

Hardness Shore ・

(15sec.@23 C)

Shore A 61-100

Shore A 56-96

Plasticizers

Phthalates series / Phthalates free series

Phthalates series / Phthalates free series

Sterilizations

Ethylene Oxide (ETO)

Ethylene Oxide (ETO)

Applications

Soft medical tubings Heart / lung bypass kits Blood tubings Blood / I.V. containers Endotracheal tubings Drip chamber components Stiff medical tubings Soft molding components Face Masks Enema Nozzles Blood transfusion and dialysis components Blood transfusion set components Tubing connectors Drip chamber components

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High flow rigid injection

Shore D

Phthalates series / Phthalates free series

Super elastic recovery

Shore A 61-70

Phthalates series / Phthalates free series

Ethylene Oxide (ETO)

Luer components Drip chamber connectors Filters I.V. components

Ethylene Oxide (ETO)

Peristaltic pump tubings Connection tubings


http://www.sunder.com.tw

SUNDER BIOMEDICAL TECH. CO., LTD. Taiwan Headquarters 10F-1, No. 1-67, W u-Chuan Rd., W. Dist., Taichung 40348, Taiwan R. O. C. Tel : + 886-4-2375-5650 Fax : + 886-4-2375-5651 Pao-Chung Factory No. 16, Chung-Chen Rd., Chung-M ing Village,Pao-Chung Hsiang, Yunlin Hsien 63441, Taiwan R. O. C. Tel : + 886-5-697-6985 Fax : + 886-5-697-6986 Fu-Xing Factory No.57, Da-Lun Street., Da-Lun Village, Fu-Xing Siang,Changhua County 50641, Taiwan R. O. C. http://www.sunder.com.tw e-mai l : sales@sunder.com.tw e-mail:

2011.11@03


Sunder catalogs 103