Tourniquet,latex-free,50cm

GENERAL DESCRIPTION
Tourniquet, two models: one elastic another with a buckle. If requestors have a preference, these should be indicated at the time of ordering.

INTENDED USE
A strap or tubing intended to be wrapped around a patient's limb (arm or leg) and manually tightened to reduce blood circulation to or from the portion of the limb distal to where the device is applied. It is typically used by emergency medical services (EMS) for emergency blood loss prevention or for routine blood sampling.

TECHNICAL SPECIFICATIONS
Tourniquet used to compress a limb to stop blood flow.
Solid elastic strip.
Material: Latex free.
Width: for solid design: 1.8-2.3 cm
Length: 50-75 cm
Reusable, non-sterile
Autoclavable at 121°C.

SHELF LIFE
Not applicable.

ESTIMATED LIFE SPAN
Five to ten years depending on the model supplied.

WARRANTY
One or three years depending on the model supplied.

ENVIRONMENTAL CONDITIONS
Storage conditions: 0 - 50°C / 85% RH.
Operating conditions: 10 - 40°C / 85% RH.

WEIGHT AND VOLUME (Packaged)
Weight: 55 gr.
Volume: 0.2 dm³.

INSTALLATION / COMMISSIONING REQUIREMENTS
No installation or commissioning requirements.

TRAINING REQUIREMENTS
No user training will be required.

MAINTENANCE/USER REQUIREMENTS
No maintenance requirements.

COMPONENT OF A KIT
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QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes.
- Supplier is certified for ISO 9001 Quality management systems – Requirements.

MARKET CLEARANCE AND DEVICE CLASSIFICATION
CE certified under the EU MDR 2017/745 as Class I device.

NOMENCLATURE
GMDN Code: 58128