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< RETOUR

NO-AIR INTAKE TRANSFUSION SET STERILE DEHP-FREE BPA-FREE MOBILE LUER LOCK, 3x4.1MM

Reference : TRAMF001

  • Bisphenol A and DEHP free (<0.1% m/m.)
  • Roller clamp ABS
  • Mobile Luer lock and purge filter
  • Pyrogen-free

 

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Description
Description

Transfusers differ from infusers as they are equipped with a filter, covering about half of the drip chamber surface, with a porosity of 200 µm.
This calibration allows blood cells and labile blood products to pass through without compromising their integrity, while filtering out any aggregates that may have formed during storage.

Transfuser with:
- Perforator: Four channel - 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. Diameter: 3x4.1mm

- End fitting: Mobile Luer Lock with purge filter (automatic line purge) inlcuded in the protective cap : hydrophobic membrane, with automatic ventilation technology that stops when finished to prevent leaks.

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.

For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.


The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Made in China.

Technical
information
Technical
information

Indications 
This medical device is intended for the administration of blood or blood derivatives. Gravity transfusion set, do not use with pressure. Do not use as an infusion set.

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
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized 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 / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Logistics
information
Logistics
information

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 0.004 3661809014536
BOX 100 38 x 28 x 32 4.100 3661809114533
CASE 400 59 x 39 x 66 17.000 3661809214530
Request the technical sheet

Transfusers differ from infusers as they are equipped with a filter, covering about half of the drip chamber surface, with a porosity of 200 µm.
This calibration allows blood cells and labile blood products to pass through without compromising their integrity, while filtering out any aggregates that may have formed during storage.

Transfuser with:
- Perforator: Four channel - 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. Diameter: 3x4.1mm

- End fitting: Mobile Luer Lock with purge filter (automatic line purge) inlcuded in the protective cap : hydrophobic membrane, with automatic ventilation technology that stops when finished to prevent leaks.

For disinfection of connections, preferably use 70° alcohol which ensures very good compatibility. More and more often, caregivers are using 2% chlorhexidine in 70% isopropyl alcohol. This type of solution is known to be very aggressive for plastic materials.

For this reason Didactic has conducted laboratory tests of contact connections with this type of disinfectant agent.


The results showed that the connections provided fairly good resistance to this composition when the contact is relatively short (less than 1 minute) with a compress soaked in disinfectant solution without excess (1 to 2ml per compress).

Made in China.

Indications 
This medical device is intended for the administration of blood or blood derivatives. Gravity transfusion set, do not use with pressure. Do not use as an infusion set.

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
  • Infusion equipment for medical purposes - Part 14: Clamps and flow limiters for non-contact fluid transfusion and infusion devices
  • Sterilization of medical devices - Requirements for medical devices to be designated lt;STERILE lt; - Part 1: Requirements for terminally sterilized 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 / 216 Rue Roland Moreno - 76210 Saint-Jean-de-

Transport conditions 

Protected from light, humidity and heat

Conditioning Parts quantities Dimensions in cm Weight in kg Ean 13 of conditioning
UNIT 1 0.004 3661809014536
BOX 100 38 x 28 x 32 4.100 3661809114533
CASE 400 59 x 39 x 66 17.000 3661809214530

Request for technical documentation

  • Didactic formally undertakes not to sell, rent or exchange any personal information. In application of articles 39 and following of the law of January 6, 1978 modified relating to data processing and freedoms (CNIL), you have the right to access, delete and rectify information concerning related to you.