Didactic - Model TRAMF001 - No-Air Intake Transfusion Set
Transfuser with: Perforator: Single channel, bevelled; Chamber: Semi-rigid, volume 20ml, Calibrated at 20 drops = 1g of distilled water at 20°C; 200 µm filter particle; Flow regulator: Precise and reliable, Adelberg® IV wheel; Tubing: PVC designed for comfort, optimal flow adjustment consistency and to prevent kinks; End fitting: Mobile Luer Lock with purge filter (automatic line purge).
- Bisphenol A and DEHP free (<0.1% m/m.)
- Roller clamp ABS
- Mobile Luer lock and purge filter
INDICATIONS
This medical device is intended for the administration of blood or blood derivatives
USED MATERIALS
PVC: chamber, tubing - PE: protective cap - Polypropylene: particle filter - Polyethylene: purge filter - Acrylonitrile Butadiene Styrene: perforator, regulator, Luer Lock - Polyamide mesh: particle filter.
LABELING
on each unit are written the reference, the lot/serial number, the sterilization method and the expiry date if applicable
MEDICAL DEVICE
- MD class : IIa
- MD notified body : 1370
- EU directive/regulation : 93/42/CEE - 2007/47/CEE
- annexe : II
STERILE
- sterile : yes
- sterilization method : ethylene oxide
CONFORMITY
- Sterilization of health-care products - Ethylene oxide - Requiremnets for the development, validation and routine control of a sterilization process for medical devices
- Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
- Transfusion equipment for medical use — Part 4: Transfusion sets for single use, gravity feed
- Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ECONOMIC OPERATOR
- MANUFACTURER : DIDACTIC / 1800 route des bleuets, Le Mirlibut 76430 Et