Product Characteristics:
- The device has been design for special necessities of infusion therapy. Universal female 6% tapper for compatibility with any international product.
- The device comprises a siliconised 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 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.
- The device is specially designed meant for high risk cases where extra opening is not permitted to prevent risk of infection and symmetrical design facilitates cannulation on contoured surfaces.
- The device is enable with special designed Needle sheath for completely encloses the used needle for easy and safe disposal.
- Specially designed flow control hub with hydrophobic filter, for fast air filtration or sterile venting and provide rapid flow of blood and easy flashback.
- The product is designed with completely transparent flashback chamber allows quick visualization of venous return/flashback.
- The device 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 Material as per USP standards Class VI.
Product Variants:
- Color coded body as per EN ISO 10555
- Specially designed Flow Control Hub with Hydrophobic filter
- Available with dented needle for instant confirmation of flashback
- Available in Gauges 14/16/18/20/22/24 & 26 which specification meets international standards
- Packaging option available in rigid PVC with Medical Kraft Paper
- Thin walled Catheters with PTFE Clear/ Radiopaque line, PUR, FEP OR ETFE are also available
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
10
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
33
25
19
19
Packing Inner/Outer
100/1000
Material Composition
Component
Material
Material
Catheter Body
Polypropylene
Needle Hub
K-Resin
Flow Control Hub
ABS-Transparent
Catheter Holder
Polyacetal
Catheter
PTFE/PUR/FEP/ ETFE
Cannula/Needle
Stainless Steel
Needle Sheath
Polypropylene
Packaging Material
Item
Material
Individual Sterile Packaging (Blister)
Medical Grade Paper 60GSM with Standard Rigid 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 is intended for infusion therapy and also used for blood sampling
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 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-HHSUPER
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