Tubing, oxygen supply, 7.6 mtr

GENERAL DESCRIPTION
Tubing designed for external connection of an oxygen delivery source to a device used to administer oxygen such as a nasal oxygen cannula or catheter. Length 7.6 meter (25 feet).

TECHNICAL SPECIFICATIONS
Tubing (bulk coil) suitable for delivering oxygen or oxygen/air mixtures.
Translucent, flexible and soft plastic tubing of uniform diameter.
Semi-rigid, star lumen, design, made of medical grade PVC, latex free.
Anti-kink tubing, non-permanent deformation if kinked or bent too tight.
Rubber or soft plastic tubing, semi-rigid, PVC or other material, FDA Title 21 / USP VI compliant and certified for medical use, hardness > 60 Shore A (ASTM D-2240).
Length: 7.6 mtr (25 feet).
Tubing terminated with standard or universal connectors.
Individually packed.
Non-sterile.
Single use.

OPERATING CONDITIONS
At minimum,
- Temperature: 10 °C to 40 °C,
- Relative humidity: 75+/-5%

STORAGE CONDITIONS
At minimum,
- Temperature: 0 °C to 40 °C,
- Relative humidity: 75+/-5%

SHELF LIFE
5 years

WEIGHT AND VOLUME (packaged)
Weight: 0.194kg
Volume: 0.15m3

PACKAGING/LABELLING
Unit presentation: 1 tube in a plastic bag
Labelling on primary packaging must include:
- Name and/or trademark of the manufacturer
- Manufacturer's product reference
- Type of product and main characteristics
- If the packaging is not transparent, it must bear a diagram showing the essential parts of the product
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (or equivalent harmonised symbol)
- Information for handling, if applicable (or equivalent harmonised symbol)

APPLICABLE STANDARDS AND CERTIFICATIONS
Valid ISO 13485 certificate for manufacturer’s QMS
Valid CE 93/42 or equivalent marketing approval certificate
ISO 15001:2010 Anaesthetic and respiratory equipment – Compatibility with oxygen.
ISO 10993:2018 Biological evaluation of medical devices
BS EN 13544-2:2002+A1:2009 Respiratory therapy equipment. Tubing and connectors