No items found.
Product Characteristics:
- The product Flow Regulator Extension Set comprises with USP Class VI compliant, soft (<75 shore), highly kink- resistant , medical tubing in standard gauge DEHP-free PVC OR PVC to confirm to international guidelines.
- The device comprises a special designed male luer with ribs for easy gripping and connection to patient-side IV access and female luer with wings for easy gripping and attachment to IV fluids access (as per ISO-594);.
- The product having an Ergonomic dial design with ridges for easy gripping and adjustment to control the flow rates from 5 to 250 ml/hr and double scale for 10% and 40% solution strengths.
- The product compromises a collared long Y-site with self‐sealing latex-free septum; to provide optimal secondary site for bolus IV injection.
- The product does not compromise with the clinical condition or the safety of patients and reduces mechanical stress and intimal injury to blood vessel.
- The product Flow Regulator Extension Set is to be used in ambient conditions and should be used ONLY by a qualified doctor or a paramedic.
Product Variants:
Following variants areavailable for the product Flow Regulator Extension Set:
- Available with PVC or DEHP-free tubing
- Photo-protected (Light-negative) tubing
- Male Luer Slip, Male Luer Lock OR with Rotating Male Luer Lock
- Y-Injection site (self-sealing latex-free septum OR Needle-less Luer-activated access site)
- Standard OR customized tube length available
- Individually packed/sterilized in paper pouch OR soft blister
Specifications
Catheter
Material Composition
Component
Material
Material
Dial Flow Regulator
ABS+ TPE
Rigid Plastic
Threaded Stopper
HDPE
Plastic Granules
Female Luer Lock
PC (Poly-Carbonate)
Plastic Granules
Tube
PVC OR DEHP-free PVC
PVCGranules
Male Luer Lock
PC (Poly-Carbonate)
Plastic Granules
Packaging Material
Item
Material
Individual Sterile Packing (Blister)
Soft peelable PP/PE film 100 Micron Medical Kraft Paper 70 GSM
Inner Pouch (25/50)
LD Pouch
Master Carton (100/200)
Kraft-Pulp Paper
Definition Of Abbreviations:
ABS – Acrylonitrilebutadiene styrene
HDPE – High DensityPoly Ethylene
PVC – PolyvinylChloride
DEHP – Bis(2-ethylhexyl) phthalate
TPE ‐Thermoplastic Elastomers
Usage Information
EXPIRATION/VALIDITY
Shelf life 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 Flow Regulator Extension Set is intended for infusion/transfusion therapy
RECOMMENDED MAXIMUM TIME OF USE
Depends on type of medication and other factors; refer to your facility’s guidelines or CDC guidelines.
TESTING & ANALYSIS
Testing for 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
Product Codes and References
GMDN Code:
16789
UMDNS Code:
11010
Ref.No
TDS-HHFR
Have Questions?
Contact UsReady for your purchase?
Request Sample
Need it in a document?
Download Datasheet
