Product Characteristics:
- Safety I.V. Cannula pioneered the movement to innovative safety design that protect the healthcare worker from the risks associated with accidental needle-stick injuries, tapered hub for insertion ease and patient comfort.
- Safety IV cannula enables a needle safety feature that protects the users, i.e. Needle shield fully encapsulates the needle tip once activated to minimize needle-stick injury during cannulation.
- The unique, large volume chamber allows clear visual conformation through flashback and easy handling.
- Safety IV cannula device designed to help protect healthcare workers as well as hospital waste handlers from exposure to blood borne pathogens via needle-stick and mucocutaneous injuries.
- Safety IV cannula comprises a siliconized Stainless Steel Needle; Sharp needle technology provides both ease of penetration and improved patient comfort during cannulation.
- Safety IV cannula is made of best-in-class medical grade kink resistant and biocompatible PUR Catheters, with extremely smooth inner and outer surfaces to ensure easy venipuncture with minimum trauma, gently tapered catheter tip aligns with the needle bevel to provide smooth transition from needle to catheter.
- Thumb grip of the device is ergonomically designed to allow for a variety of user techniques to aid insertion.
- Safety IV cannulas do not contain elasticized PVC or natural rubber latex and can be used for Taxol administration.
- Safety IV cannula does not compromise the clinical condition or the safety of patients and reduces mechanical stress and intimal injury to blood vessel.
- Safety IV cannula is to be used in ambient conditions and should be used ONLY by a qualified doctor or a paramedic.
Special Characteristics:
- Customized automated tipping technology for lower penetration forces.
- Minimum clearance between catheter and needle to avoid peel-back.
- Catheter Materials as per USP standard Class VI.
Product Variants:
Following variants are available for the product Safety IV Cannula:
- Universal Color coded to indicate catheter gauge at a glance as per EN ISO-10555
- Available in 14/16/18/20/22 & 24 gauges which specification meets international standards.
- Unit packing option available in PP/PE Film with Tyvek Paper.
- Thin walled Catheters with PTFE Radio-opaque & PUR Radio-opaque are also available.
Specifications
Gauge
14
16
18
20
22
24
Color of Catheter Body
Orange
Grey
Green
Pink
Blue
Yellow
Flow Rate ml/min
270
200
85
55
33
18
Ext. Dia mm
2.1
1.8
1.3
1.1
0.9
0.7
Catheter
Ext. Dia mm
2.1
1.8
1.3
1.1
0.9
0.7
Effective Length mm
32/45
32/45
32/45
25/32
19/25
19
Packing Inner/Outer
50/500
Material Composition
Component
Material
Material
Catheter
PUR/PTFE
Catheter holder
POM
Hub cover with filter
PP
Body (Catheter Hub)
PP
Silicon Tube (Valve)
Silicon Rubber
Needle
Stainless Steel
Needle Cover
PP
Flip type port cap
PP
Filter
ACRYLIC
Metallic Clip
Stainless Steel
Luer Lock Cap
HDPE
Needle Hub
K-Resin/SBC
Packaging Material
Item
Material
Individual Sterile Packing (Blister)
PP+PE film with Tyvek/Paper
Inner Carton
Duplex Board
Master Carton
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 as per EN ISO 10993-7.
INTENDED USE
The Product Safety IV cannula is intended for infusion/transfusion therapy through peripheral venous access.
RECOMMENDED MAXIMUM TIME OF USE
96hrs as per CDC guidelines
TESTING & ANALYSIS
Testing for sterility, pyrogen content and physical characteristics (leakage testing, flow rate of lumen, penetration force, packaging integrity, etc.) are 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 Safety I.V Cannula is biologically safe as the device meets the requirement of ISO-10993.
Product Codes and References
GMDN Code:
40601
UMDNS Code:
10727
Ref.No
TDS-TS2
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