Product Characteristics:
- It is a safety device that protects the users, i.e. healthcare professionals from accidental needle-stick injury during IV cannula insertion. The key feature of this device is a mechanism to completely enclose the needle in a secure plastic chamber, immediately after catheter insertion.
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- It provides complete protection to healthcare workers as well as hospital waste handlers from accidental needle-stick injuries and prevents transmission of blood-borne pathogens from patients.
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- It comprises an siliconised and ground Stainless Steel with ultra-thin, ultra-sharp needle with triple facet bevel to ensures smooth and painless venipuncture during cannulation thus reducing pain and discomfort experienced during the insertion.
- It is made of best-in-class kink resistant and biocompatible PTFE or PUR 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.
- It is designed with transparent flashback chamber allows quick visualization of venous return and ensure smooth flow of blood OR any other fluid.
- It does not compromise the clinical condition or the safety of patients and reduces mechanical stress and intimal injury to blood vessel.
- It 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:
Following variants are available for this product:
- Unit packing Soft blister in Medical Grade Paper or Tyvek.
- Thin walled Catheter : PTFE radiopaque or PUR radiopaque
- 20-22-24G with hole in the needle for quick flash (optional)
Specifications
Product Details for Blood Control Safety IV Cannula
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
Effective Length of catheter (mm)
2.1
1.8
1.3
1.1
0.9
0.7
Catheter
Effective Length of catheter (mm)
2.1
1.8
1.3
1.1
0.9
0.7
Effective Length mm
45
30/45
30/48
25/30/48
25
14/19
Packing Inner/Outer
50/200
Material Composition
Component
Material
Material
Catheter
PUR/PTFE
Body (Catheter Hub)
PP
Needle hub
K-Resin/SBC
Catheter holder
POM
Locking Clip
Polyacetal (POM)
Front chamber
PC
Back chamber
PP
Needle
Stainless Steel
Needle cover
PP
Porous Plug
PE
Spring
Stainless Steel
Packaging Material
Item
Material
Individual Sterile Packing (Blister)
Medical Grade Paper/Tyvek with Soft Film
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 of 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 Blood Control Safety IV Cannula is intended to sample blood, monitor blood pressure, or administer fluids. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy, procedure being performed, fluids being infused, and duration of 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.) 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 Blood Control Safety IV Cannula complies with requirements for biocompatibility as per EN ISO-10993-1.
Product Codes and References
GMDN Code:
40601
UMDNS Code:
10727
Ref.No
TDS-RSBC
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