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Product Characteristics:
- The device 3-Way stopcock is designed to provide an additional port for infusion and/or bolus injection between the infusion line and the venous access.
- The body of the stop cock has a smooth and regular bore, designed to allow maximum fluid flow without any turbulence or formation of air bubbles, even at high pressure.
- The device 3 Way Stop Cock has a fully transparent polycarbonate body for easy visualization of
- flow. The device is also available in lipid-resistant transparent material for administration of lipid-containing IV fluids.
- The device 3-Way Stopcock has two female connectors and one male connector with universal 6% taper (as per ISO-594). The device may be used as a protective stopper for any standard femaleand/or male Luer.
- The device is leak-proof up to 5 bar (72.5 psi)
- The device 3-Way Stopcock has a uniform and fixed dead space for accurate drug administration.
- Smooth rotation of the tap over 360° is possible using single-hand operation.
- The product 3-Way Stopcock is designed and manufactured to ensure smooth flow of blood at high pressures.
- The device 3-Way Stopcock is designed for Smooth and jerk-free operation with arrow Indication Marks to indicate the direction of Flow.
- The device 3-Way Stopcock does not compromise the clinical condition or the safety of patients and minimizes mechanical stress and intimal injury to blood vessel.
- The device 3-Way Stopcock is to be used in ambient conditions and should be used ONLY by a qualified doctor or a paramedic.
Product Variants:
Following variants are available for the product Three-Way Stopcock :
- Blue, Red OR White Tap
- Packed in Rigid OR soft blister unit packing*
- With color identification PEG
- Click at every 45° rotation
*Bulk (unpacked and non-sterile) product is also available; Blister with Tyvek also available for Product.
Specifications
Specification and Packing Details for Three-Way Stopcock:
Flow Rate in ml/min
525 ± 10%
Color of Tap
Blue, Red, White
Inner Packing
50 Pcs
Outer Packing
500 Pcs
Catheter
Outer Packing
500 Pcs
Material Composition
Component
Material
Material
Body 3-Way Stopcock
Lipid resistant PC (Polycarbonate)
Tap
HDPE
Threaded Stopper
HDPE
Rotator
PC (Polycarbonate)
Plain Stopper
PP (Polypropylene)
Packaging Material
Item
Material
Individual Sterile Packing (Blister)
Soft PP/PE OR Rigid PVC film, and Medical Kraft Paper 60/70 GSM OR Tyvek
Inner Carton (50)
Duplex Board
Master Carton (500)
Kraft-Pulp Paper
Usage Information
EXPIRATION/VALIDITY
5 years from date of manufacturing
METHOD OF DISPOSAL
Medical devices and sharps contaminated with blood or other body fluids must be discarded in special containers and disposed off by incineration. Disposal must be in conformity with relevant national/international standards. Please refer to hospital protocols for disposal.
METHOD OF STERILIZATION
Terminal Ethylene Oxide (EtO gas) Sterilization; residual EtO gas within normative limits
INTENDED USE
The product 3-Way Stopcock is intended for infusion therapy
RECOMMENDED MAXIMUM TIME OF USE
96 hrs as per CDC guidelines
TESTING & ANALYSIS
Testing of sterility, pyrogen content and physical characteristics (leakage testing, flow rate of lumen, packaging integrity, etc.) is performed on each batch before release.
STORAGE
Store in a cool and dry place at room temperature away from moisture, direct sunlight and heat sources.
BIOCOMPATIBILITY
The product 3-Way Stopcock complies with requirements for biocompatibility as per ISO-10993 international standard, based on testing of the finished device
Product Codes and References
GMDN Code:
32172
UMDNS Code:
13803
Ref.No
TDS-HH3WSC
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