sunder catalogs 103
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
SUNDER BIOMEDICAL TECH. CO., LTD.SUNDER BIOMEDICAL TECH. CO., LTD.
QualityQuality ReliabilityReliability ExcellenceExcellence
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
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GR
OU
PS
UN
DE
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RO
UP
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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
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
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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
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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 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
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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
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
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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
CO
MP
ON
EN
TS
CO
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ON
EN
TS
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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
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
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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
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PVC COMPOUNDS FOR MEDICAL APPLICATIONS
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.
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OVERALL SPECIFICATIONS & APPLICATIONS
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