Product Characteristics:
- The I.V Cannula has been designed specially with small wings and W/O injection port, to assist infusion therapy amongst neonates. 6% luer tapper for compatibility with any international product.
- The device comprises a siliconized and ground Stainless Steel with ultra-thin, ultra-sharp needle with triple facet bevel to ensure smooth and painless venipuncture during cannulation thus reducing pain and discomfort experienced during the insertion.
- The device is made of best-in-class kink resistant and biocompatible Catheter, 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.
- The device is enabled with small wings specially designed for easy gripping and safe clamping to allow secure fixation to skin.
- The product is designed with flashback chamber for immediate confirmation of venipuncture. ** Specially designed filter hub cover with hydrophobic filter, for fast air filtration or sterile venting and provide rapid flow of blood and easy flashback.
- The product does not compromise the clinical condition or the safety of patients and reduces mechanical stress and intimal injury to blood vessel.
- The device 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.
- CatheterMaterial as per USP standards Class VI.
Product Variants:
- Color coded body as per EN ISO-10555.
- With Normal or Filter Hub Cover**.
- Gauges : 14/16/17/18/20/22/24/26.
- Packing option available with Medical Grade Paper or Tyvek.
- Thin walled Catheters with Teflon PTFE Clear/Radiopaque or FEP R/O or PUR R/O.
- Also available with wing cover, as an additional support during cannulation as well as works as a sheath for wings.
Specifications
Specification and Packing Details :
Gauge
14
16
18
20
22
24
26
Color of Body
Orange
Grey
Green
Pink
Blue
Yellow
Violet
Flow Rate ml/min
270
200
85
55
33
18
10
Ext. Dia mm
2.1
1.8
1.3
1.1
0.9
0.7
0.6
Catheter
Ext. Dia mm
2.1
1.8
1.3
1.1
0.9
0.7
0.6
Effe. Length mm
45
45
32/45
32
25
19
19
Packing Inner/Outer
100/1000
Material Composition
Component
Material
Material
Catheter Body
Poly Propylene
Needle Hub
Poly Propylene
Threaded Stopper
High Density Polyethylene
Teflon Holder
Polyacetal
Catheter
PTFE/FEP/PUR
Cannula/Needle
Stainless Steel
Hub Cover
Poly Propylene
Packaging Material
Item
Material
Individual Sterile Packing (Blister)
Medical Grade Paper /Tyvek with Standard PVC film
Inner Carton (100)
Duplex Board
Master Carton (1000)
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 IV Cannula is intended for infusion/transfusion therapy.
RECOMMENDED MAXIMUM TIME OF USE
96 hrs. 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.) 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 IV Cannula complies with requirements for biocompatibility as per ISO-10993 international standard, based on testing of the finished device.
Product Codes and References
GMDN Code:
40601
UMDNS Code:
10727
Ref.No
TDS-HHIVC1W
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