IV Cannula without wings & without port

IV Cannula without wings & without port is a Class IIa/Rule 7 (classification as per MDD/93/42/EEC) medical device that is used for peripheral intravenous access. The device serves as a conduit for any fluid OR blood vessel of the patient.
IV Cannula without wings & without port
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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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