sunder catalogs 103

16
SUNDER BIOMEDICAL TECH. CO., LTD. SUNDER BIOMEDICAL TECH. CO., LTD. Quality Quality Reliability Reliability Excellence Excellence

Upload: taiwan-sunder

Post on 23-Feb-2016

221 views

Category:

Documents


0 download

DESCRIPTION

Sunder quality system relies on a strict manufacturing practice (GMP) and conform to ISO9001、ISO13485 and comply with the EEC93/42 directive on medical devices audited by DNV. More highlighting to our reliability, our main items of hemodialysis blood tubing sets and A.V. fistula needle sets obtained the pre-market approval , and several items are pending to apply. Most of our manufacturing items are also obtained CE mark as well as other countries' certification like CCC of China, PRC and KFDA of Korea.

TRANSCRIPT

Page 1: Sunder catalogs 103

SUNDER BIOMEDICAL TECH. CO., LTD.SUNDER BIOMEDICAL TECH. CO., LTD.

QualityQuality ReliabilityReliability ExcellenceExcellence

Page 2: Sunder catalogs 103
Page 3: Sunder catalogs 103

We have set one overseas office in Singapore, three factories worldwide locating in Taiwan, China, and Thailand; and one medical grade PVC compound factory in Taiwan.

Establishment : 16th July 1998

Taiwan Employees : 200 people

Worldwide Employees : 340 people ~

SUNDER headquarter is in Taichung, Taiwan.

http://www.sunder.com.tw

EC REP

China Changhua

Tianjin

(Office)Singapore

Taiwan

Yunlin (Factory)(Factory)(Factory)

Taichung (Headquarter)

SU

ND

ER

GR

OU

PS

UN

DE

R G

RO

UP

1

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 efficient service are integrated components of our quality system. All our products are manufactured in class-10,000 clean rooms.

Well Kang Ltd (www.well-kang.com)The Black Church,St.Mary's Place,Dublin7,Ireland

Page 4: Sunder catalogs 103

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.

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.

ETO Sterilization

DEHP Free / Non-P

2

Page 5: Sunder catalogs 103

General specification:

All customized bloodlines are available on request.

Drawing of Standard Type:

OEM & ODM are available on request.

Model

Pump Segment

Inside and outsideDiameters (mm)

Main Tube

Inside and outsideDiameters (mm)

Drip Chamber Code

"K" Series

"G" Series

"S" Series 6.4 x 9.8

6.4 x 9.8

8 x 12

4.4 x 6.6

4.4 x 6.6

4.4 x 6.6

SI-00602SI-00607

SI-00604

SI-00602

ETO STERILIZATION

PR

OD

UC

TS

PR

OD

UC

TS

3

Page 6: Sunder catalogs 103
Page 7: Sunder catalogs 103

A.V. FISTULA NEEDLE SET

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

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

FeaturesUnique process on blade to reduce painUnique process on blade to reduce skin damageUltra wall and siliconized fistula needle with or without back eyeFlexible fixed or rotating wing for easy slip-free puncture operationClear kink resistant tube fitted with Female Luer lock & pinch clamp

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.3

12

TYPE NO.

Package

Wing colorWing type Needle diameter

SD-A15G-4

SD-A15G-6SD-A15G-5

SD-A15G-1

SD-A15G-3SD-A15G-2

RotatingRotatingRotating

FixedFixedFixed

Blue

BlueBlueBlueBlue

Blue1.8 1"

1.1/2"

1.1/2"

1.1/4"

1.1/4"

1"

1.81.81.81.81.8

Needle length(inch)(mm)

SD-A17G-4

SD-A17G-6SD-A17G-5

SD-A17G-1

SD-A17G-3SD-A17G-2

RotatingRotatingRotating

FixedFixedFixed

1.4 1"1.1/2"

1.1/2"

1.1/4"

1.1/4"

1"

1.41.41.41.41.4

SD-A16G-4

SD-A16G-6SD-A16G-5

SD-A16G-1

SD-A16G-3SD-A16G-2

RotatingRotatingRotating

FixedFixedFixed

1.6 1"1.1/2"

1.1/2"

1.1/4"

1.1/4"

1"

1.61.61.61.61.6

GreenGreenGreenGreenGreenGreen

OrangeOrangeOrangeOrangeOrangeOrange

(cm)Tube length

303030303030303030303030303030303030

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)

5

PR

OD

UC

TS

PR

OD

UC

TS

Page 8: Sunder catalogs 103
Page 9: Sunder catalogs 103

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

PC-LT ( II )Code No. : SI-00102Material : PVCFor O.D. 6.6mm tubeColor : Transparent

PC-LT ( VII )Code No. : SI-00106Material : PVCFor O.D. 6.8mm tubeColor : Transparent

REVOLVING LUER LOCK CONNECTORS

LOCK ( I ) Code No. : SI-00201Material : PPColor : Blue

LOCK ( II ) Code No. : SI-00203Material : PPColor : Blue

LOCK ( II )Code No. : SI-00204Material : PPColor : Red

LOCK RING

LOCK ( I )Code No. : SI-00202Material : PPColor : Red

LUER LOCK CONNECTORS WITH LOCK RING

Luer lock connectorCode No. : SI-00401Material : PVCFor O.D. 3.6mm tubeColor : Blue

Luer lock connectorCode No. : SI-00402Material : PVCFor O.D. 3.6mm tubeColor : Red

FEMALE LUER LOCK

Luer lock connectorCode No. : SI-00406Material : PVCFor O.D. 4.8mm tubeColor : Transparent

Luer lock connectorCode No. : SI-00416Material : PVCFor O.D. 5.5mm tubeColor : Transparent

Luer lock connectorCode No. : SI-00417Material : PVCFor O.D. 5.5mm tubeColor : Transparent

Luer lock connectorCode No. : SI-00418Material : PVCFor O.D. 5.5mm tubeColor : Transparent

Luer lock connectorCode No. : SI-00403Material : PVCFor O.D. 2.4mm tubeColor : Red

Luer lock connectorCode No. : SI-00404Material : PVCFor O.D. 1.9mm tubeColor : Red

Luer lock connectorCode No. : PI-00160Material : PVCFor O.D. 4.1mm tubeColor : Transparent

T-Injection Site Code No. : SI-00301Material : PVCFor O.D. 6.6mm tubeColor : Blue

T-Injection SiteCode No. : SI-00302Material : PVCFor O.D. 6.6mm tubeColor : Red

INJECTION SITES

T-Injection Site (with silicon plug) Code No. : SI-00313Material : PVCFor O.D. 6.8mm tubeColor : Blue

T-Injection Site(with silicon plug)Code No. : SI-00314Material : PVCFor O.D. 6.8mm tubeColor : Red

T-Injection SiteCode No. : SA-00110Material : PVCFor O.D. 6.6mm tubeColor : Blue

T-Injection SiteCode No. : SA-00111Material : PVCFor O.D. 6.6mm tubeColor : Red

PRIMING CONNECTORS

Recirculating luer lockCode No. : SI-01302Material : PPLuer lock priming Color : White

Recirculating luer lockadaptorCode No. : SI-01305Material : PPLuer lock primingColor : White

All bloodline set components and accessories are available.

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.

BLOOD LINE SET CUSTOM MADE

COMPONENTS & ACCESSORIES

CO

MP

ON

EN

TS

CO

MP

ON

EN

TS

7

Page 10: Sunder catalogs 103

8

Clamp- L Code No. : SI-00514Material : PPBig clampColor : Blue

Clamp-LCode No. : SI-00515Material : PPBig ClampColor : Red

Clamp-SCode No. : SI-00526Material : PPSmall ClampColor : Blue

Clamp-SCode No. : SI-00527Material : PPSmall ClampColor : Red

Clamp-SCode No. : SI-00525Material : PPSmall ClampColor : White

Clamp- L Code No. : SI-00517Material : PPBig clampColor : White

CLAMPS

Cap for female lockCode No. : SI-00801Material : PP/PEColor : Transparent

Cap for dialyzer adaptorCode No. : SI-00903Material : PP/PEColor : Transparent

CAPS

SPIKE

Spike(ll)Code No. : PA-00021(Spike set)PI-00449(Spike)L=65.6mmMaterial : ABSFemale Luer Connector SpikeColor : White

Spike(lll)Code No. : PA-00023(Spike set)PI-01122(Spike)L=65.6mmMaterial : ABSFor O.D. 4.1mm tubeColor : White

SpikeCode No. : SA-00109(Spike set) SI-01512(Spike)L=54mmMaterial : ABSFor O.D. 5.5mmx2 tubeColor : White

Drip chamber Code No. : SI-00620Material : PVCTop side O.D. 24.6mmL=117.3mmFor O.D. 6.6mm tubeTotal volume =20mlColor : TransparentFilter : SI-01206

Drip chamber (II)Code No. : SA-00129Material : PVCTop side O.D. 30.4mmL=120mmFor O.D. 6.8mm tubeTotal volume =20mlColor : Transparent

Drip chamberCode No. : PI-00443Material : PVCFor O.D. 4.1mm tubeColor : Transparent

DRIP CHAMBERSDrip chamberCode No. : SI-00618Material : PVC / Shore A 86-88Top side O.D. 24.6mmL=122.0mmFor O.D. 6.6mm tubeTotal volume =25ml Color : TransparentFilter : SI-01201

Drip chamber Code No. : SI-00602Material : PVC / Shore A 86-88Top side O.D. 24.6mmL=122.3mmFor O.D. 6.6mm tubeTotal volume =25mlColor : TransparentFilter : SI-01201

Drip chamberCode No. : SI-00604Material : PVC / Shore A 86-88Top side O.D. 20.6mmL=116.6mmFor O.D. 6.6mm tubeTotal volume =20mlColor : TransparentFilter : SI-01202

Drip chamber Code No. : SI-00607Material : PVC / Shore A 86-88Top side O.D. 30.4mmL=124mmFor O.D. 6.6mm tubeTotal volume =22mlColor : TransparentFilter : SI-01201

Drip chamberCode No. : SI-00613Material : PVC / Shore A 86-88Top side O.D. 30.6mmL=128.0mmFor O.D. 6.6mm tubeTotal volume =68mlColor : TransparentFilter : SI-01202

Drip chamber Code No. : SI-00614Material : PVC / Shore A 79-81Top side O.D. 24.6mmL=122.3mmFor O.D. 6.6mm tubeTotal volume =25ml Color : TransparentFilter : SI-01202

DRIP CHAMBERS

Page 11: Sunder catalogs 103

CO

MP

ON

EN

TS

CO

MP

ON

EN

TS

9

Cover for drip chamberCode No. : SI-00728Material : PVCThree-lead top capFor 6.6,3.6,5.5mm tubesDrip chamber O.D.30.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00735Material : PVCThree-lead top capFor 6.6,3.6,3.6mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00736Material : PVCThree-lead top capFor 6.6,3.6,5.5mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00705Material : PVCThree-lead top capFor 6.6,3.6,3.6mm Tubes Drip chamber O.D. 24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00706Material : PVCTwo-lead top capFor 6.6,3.6mm TubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00711Material : PVCTwo- lead top capFor 6.6,3.6mm tubesDrip chamber O.D.20.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00713Material : PVCThree-lead top capFor 6.6,3.6,3.6mm tubesDrip chamber O.D.30.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00710Material : PVCThree-lead top capFor 6.6,3.6,3.6mm tubesDrip chamber O.D.20.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00737Material : PVCTwo-lead top capFor 6.6,3.6mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00738Material : PVCThree-lead top capFor 6.6,5.5,5.5mm tubesDrip chamber O.D.30.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00739Material : PVCThree-lead top capFor 6.6,4.1,4.1mm tubesDrip chamber O.D.30.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00741Material : PVCThree-lead top capFor 6.6,5.5,5.5mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00742Material : PVCTwo-lead top capFor 6.6,6.6mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00743Material : PVCThree-lead top capFor 6.6,5.5,4.1mm tubesDrip chamber O.D.30.0mmColor : Transparent

Cover for drip chamberCode No. : SI-00744Material : PVCTwo-lead top capFor 6.6,4.1mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00745Material : PVCThree-lead top capFor 6.6,4.1,3.6mm tubesDrip chamber O.D.24.6mmColor : Transparent

Cover for drip chamberCode No. : SI-00751Material : PVCTwo-lead top capFor 6.6,3.6mm tubesDrip chamber O.D.24.6mmColor : Transparent

TOP CAPSTOP CAPSTOP CAPS

DIALYZER CONNECTORS

Dialyzer adaptor Code No. : SI-01011Material : PVC(soft)For 6.6mm tubeColor : Blue

Dialyzer adaptorCode No. : SI-01012Material : PVC(soft)For 6.6mm tubeColor : Red

Dialyzer adaptor Code No. : SI-01013Material : PVC(rigid)For 6.6mm tubeColor : Blue

Dialyzer adaptorCode No. : SI-01014Material : PVC(rigid)For 6.6mm tubeColor : Red

Dialyzer adaptor Code No. : SI-01015Material : PVCFor 6.6mm tubeColor : Blue

Dialyzer adaptorCode No. : SI-01016Material : PVCFor 6.6mm tubeColor : Red

Filter-L Code No. : SI-01201Material : PPDimension : 16.2 mmColor : Transparent( Filter mesh -270um )

Filter-SCode No. : SI-01202Material : PPDimension : 14.5 mmColor : Transparent( Filter mesh -270um )

Filter-SCode No. : SI-01206Material : PPDimension : 14.5 mmColor : Transparent( Filter mesh -270um )

FILTERS

Page 12: Sunder catalogs 103

TRANSDUCER PROTECTOR

Code No. : PA-00010Material : PVCMale-female luer lockColor : Transparent

Code No. : SA-00097Material : PVCFor tube O.D. 5.5mmColor : Transparent

Code No. : PA-00025Material : PVCFor tube O.D. 5.5mmColor : Transparent

ROLLER CLAMP

Code No. : PI-00040Material : ABSFor 4.1mm tubeColor : White

THREE WAY CONNECTOR

Code No. : PI-00170Material : PVCFor 6.6,4.1mm tubes Color : Transparent

Code No. : SA-00010Material : PVCFor O.D. 6.6mm tube Color : Transparent

Code No. : SA-00125Material : PVC Color : TransparentFor O.D. 6.6mm tubeService Line Connector for O.D. 5.5mm tubeColor : Transparent

Code No. : SA-00130Material : PVC Color : TransparentFor O.D. 6.6mm tubeService Line Connector for O.D. 4.1mm tubeColor : Transparent

PILLOW

Male luer lock capCode No. : PI-00447Material : PPColor : Transparent

Male luer connectorCode No. : PI-00448Material : ABSColor : White

Male Luer

Code No. : PA-00367 (15G x 1”)PA-00370 (15G x 1”1/4)Material : PVCFor 5.0mm tubes Color : Blue

Code No. : PA-00368 (16G x 1”)PA-00371 (16G x 1”1/4)Material : PVCFor 5.0mm tubes Color : Green

Code No. : PA-00369 (17G x 1”)PA-00372 (17G x 1”1/4)Material : PVCFor 5.0mm tubes Color : Orange

BUTTER-FLY NEEDLE SET

RUBBER BOTTOM

Code No. : PO-00010Material : SiliconColor : Nature

A-WU CLAMP

Code No. : PI-00387Material : POM(Poluformaldehyde)Color : Blue

Code No. : PI-00388Material : POM(Poluformaldehyde)Color : Red

Code No. : PI-00240Material : POM(Poluformaldehyde)Color : White

Pump segment connectorCode No. : SI-01109Material : PVCFor O.D. 9.8mm Pump SegmentColor : Transparent

PUMP CONNECTORSPump segment connectorCode No. : SI- 01101Material : PVCFor O.D. 9.8mm Pump SegmentWith 3.6mm tubeColor : TransparentPump segment connectorCode No. : SI- 01102Material : PVCFor O.D. 9.8mm Pump SegmentWith 2.4mm tubeColor : TransparentPump segment connectorCode No. : SI-01103Material : PVCFor O.D. 12mm Pump SegmentWith 3.6mm tubeColor : Transparent

Pump segment connectorCode No. : SI-01105Material : PVCFor O.D. 12mm Pump SegmentColor : Transparent

Pump segment connectorCode No. : SI- 01106Material : PVCFor O.D. 9.8mm Pump SegmentWith 5.5mm tubeColor : TransparentPump segment connectorCode No. : SI- 01107Material : PVCFor O.D. 12mm Pump SegmentWith 4.1mm tubeColor : TransparentPump segment connectorCode No. : SI-01108Material : PVCFor O.D. 9.8mm Pump SegmentWith 2.4mm tubeColor : Transparent

Pump segment connectorCode No. : SI-01104Material : PVCFor O.D. 12mm Pump SegmentWith 2.4mm tubeColor : Transparent

Pump segment connectorCode No. : SI-01110Material : PVCFor O.D. 9.8mm Pump SegmentWith 4.1mm tubeColor : Transparent

10

Page 13: Sunder catalogs 103

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

Sunder has developed PVC compounds since 2002.

3. Heavy metals (EN-71 Part 3)Lead (Pb)

Barium (Ba)

Cadmium (Cd)

Chromium (Cr)

Antimony (Sb)

Mercury (Hg)

Arsenic (As)

Selenium (Se)

Detection limits : 0.25-1.5 ppm

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)

1. Biocompatibility test (Class VI Test-USP, 21CFR, Part 58 GMP for Non- Clinical Laboratory Studies)

(1) Systemic Injection Test

(2) Intracutaneous Injection

(3) Implant Test

PV

CP

VC

11

PVC COMPOUNDS FOR MEDICAL APPLICATIONS

Page 14: Sunder catalogs 103

Phthalates series /Phthalates freeseries

Phthalates series /Phthalates freeseries

Phthalates series /Phthalates freeseries

Phthalates series /Phthalates freeseries

Plasticizers Applications

Soft medical tubingsHeart / lung bypass kits Blood tubings Blood / I.V. containersEndotracheal tubingsDrip chamber componentsStiff medical tubings

Soft molding componentsFace Masks Enema NozzlesBlood transfusion and dialysis components Blood transfusion set components

Tubing connectorsDrip chamber components

Luer componentsDrip chamber connectorsFiltersI.V. components

Peristaltic pump tubingsConnection tubings

Ethylene Oxide (ETO)

Ethylene Oxide (ETO)

Ethylene Oxide (ETO)

Ethylene Oxide (ETO)

SterilizationsSpecifications

Clear extrusion

Clear injection

High flowrigid injection

Super elasticrecovery

Shore A 61-70

Shore D

Shore A 61-100

Shore A 56-96

(15sec.@23。C)

Shore Hardness

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 certified by USP, JP for safety assurance and with EN-71

part 3 for free-from-heavy metal inspection.

12

OVERALL SPECIFICATIONS & APPLICATIONS

Page 15: Sunder catalogs 103
Page 16: Sunder catalogs 103

SUNDER BIOMEDICAL TECH. CO., LTD.SUNDER BIOMEDICAL TECH. CO., LTD.Taiwan Headquarters Taiwan Headquarters

10F-1, No. 1-67, Wu-Chuan Rd., W. Dist. , Taichung 40348, Taiwan R. O. C.Tel : + 886-4-2375-5650 Fax : + 886-4-2375-5651

Pao-Chung FactoryPao-Chung FactoryNo. 16, Chung-Chen Rd. , Chung-Ming Village,Pao-Chung Hsiang,Yunlin Hsien 63441, Taiwan R. O. C. Tel : + 886-5-697-6985 Fax : + 886-5-697-6986

Fu-Xing FactoryFu-Xing FactoryNo.57, Da-Lun Street. , Da-Lun Village, Fu-Xing Siang,Changhua County 50641, Taiwan R. O. C.

http://www.sunder.com.twe-mail:http://www.sunder.com.twe-mai :[email protected] [email protected]

2011.11@03

http://www.sunder.com.tw