Medical device

Meditalia S.r.l., an Italian company that has long been active in the biomedical sector, produces the following medical devices:
Blood bag systems, lines of bags for collecting blood and preparing blood components.
Accessory systems, lines of bags for preparing and storing blood components.
Ozone therapy kits for storing blood during ozonated autohemotherapies.
Kifarm bags for checking blood loss during childbirth.

In addition to these medical devices, Meditalia has chosen to concentrate on innovative patents in order to create new proposals for the benefit of patients:
BioNest system is a bag system for the preparation of platelet gel from umbilical cord blood.

Solutran® Hemo blood bags

The medical devices Solutran®hemo BLOOD BAGS produced by MEDITALIA S.r.l. are sets consisting of one or more PVC bags connected with each other by means of tubes, and a venous blood sampling needle. They are designed for the collection of blood, and the preparation, storage and transfusion of blood components. They are sterile, single-use devices.

Solutran®hemo BLOOD BAGS line
The devices in the Solutran®hemo BLOOD BAGS line consist of a series of components assembled together: the principal part is the “mother” bag, which is connected to a small tube that ends with a protected donor sampling needle. One or more “satellite” bags can be connected to the mother bag in a closed circuit.
The bags contain an anticoagulant solution (CPD or CPDA-1) and, in the case of the triple and quadruple bags, a solution of SAG-M as an additive to preserve red blood cells. Some variants are equipped with a 40 mL pre-donation safety sampling bag directly connected to the mother bag.

There are four sets of bags:

• Single bags
• Double bags
• Triple bags
• Quadruple bags

Solutran®hemo BLOOD BAGS are intended to be used for the collection, storage and transfusion of blood components.
All of the devices in the Solutran®hemo BLOOD BAGS line include a mother bag in which to collect whole blood during the phase of blood donation. The product variants containing one or more satellite bags are intended to be used for the separation, transformation and storage of the components of the whole blood collected in the mother bag. The DOUBLE BAG kit is for the preparation of red blood cells and plasma; the TRIPLE BAG kit for the preparation of red blood cells, plasma and platelets; and the QUADRUPLE BAG kit for the preparation of buffy coat-depleted red blood cells, plasma, and buffy coat that can be used to prepare platelets.
All of these medical devices are intended to be used in healthcare facilities by appropriately trained and specialised personnel familiar with the instructions for use.
The medical devices Solutran®Hemo BLOOD BAGS are produced by MEDITALIA S.r.l. in conformity with the essential requirements defined in Attachment I and the contents of Attachment VII of European Directive 93/42/CEE and its subsequent integrative modifications (e.g. European Directive 2007/47/CE).


INTENDED USE

The BLOOD COLLECTION BAGS are sterile, single-use medical devices: once used to collect blood, their life depends on the storage life of the blood components they contain.
On the basis of the results of shelf-life tests carried out in accordance with the ICH shelf-life regulations in force, the foreseen life of the product itself is two years. This validity refers to correctly stored products in unopened and undamaged packaging.

CODICI PRODOTTI
Solutran® Hemo O2 O3 ozone therapy kit

The SOLUTRAN HEMO O2O3 OZONE THERAPY KIT WITH VIALS is a procedural kit that is intended to be used for ozonated autohemotherapies using a mixture of oxygen and ozone.

The treatment involves drawing a certain amount of blood from a patient, exposing the drawn blood to a mixture of oxygen and ozone, and subsequently re-infusing the ozonated blood into the same patient.

The kit is intended to be used in healthcare facilities by appropriately trained and specialised personnel familiar with the instructions for use.


TECHNICAL SPECIFICATIONS
The kit consists of:

  • 1 Solutran Hemo O2O3 sterile bag
  • 1 sterile transfusion set
  • 5 vials of 3.8% sodium citrate (380 mg/10 mL) in one box.

CE marking: Each component is compliant with the requirements laid down in European Directive 93/42/CEE and its subsequent integrative modifications (European Directive 2007/47/CE) which were transposed into Italian law by means of Law Decree No. 37 of 25.01.2010.
KIT COMPONENTS DESCRIPTION
Solutran Hemo O2O3 sterile bag: Ref.: 6990000011
Produced by Meditalia S.r.l.
CE 0373

  • 450 mL bag with graduated scale
  • 90 mm long tube, Ø 3.2×4.4
  • Swabable bag access port
  • Non-return valve
  • Hydrophobic filter, Ø 0.2 micron
  • Vented male Luer lock cap
  • Packaging bag: 38 x 25 cm

Sterile transfusion set:
Ref.: FT-NDOP0000004-BC
Produced by Ferrari L. S.r.l.
CE 0373

  • Cap for Luer lock
  • Male Luer lock fitting (fixed)
  • 3-way Y connector for tube
  • 20+70+100+20 cm tubes, Ø 3×4.1 mm.,
  • Clamps
  • Roller clamps for tubing
  • Drip tray (drop volume: 20 drops = 1 mL)
  • Cylindrical blood filter: 200 micron mesh
  • Needle-less Clave® Y connector
  • Packaging bag: 20 x 30 cm

Vials of 3.8% sodium citrate (sodium citrate 380 mg/10 mL)
Ref.: PCSA381.PSO
Produced by SALF S.p.A.

  • CE 0373 Sodium citrate dihydrate 38 g
  • Water for injectable preparations q.s. for 1000 mL
  • 10 mL glass vials

Warnings: The kit is intended for use only by specialised healthcare personnel. The kit contains single-use sterile components that cannot be re-sterilised. Phthalate free. Apyrogenic internal circuit. Keep out of sunlight and away from damp. Do not use if the package is damaged. Do not use after the expiry date indicated on the package. Do not use this medical device for a treatment period of more than 60 minutes.

The components are sterilised individually:

  • Solutran Hemo O2O3 sterile bag: ethylene oxide sterilisation
  • Transfusion set: ethylene oxide sterilisation
  • Vials of 3.8% sodium citrate: moist heat sterilisation

2 years

Solutran® hemo BioNest

The BioNest system has been developed to facilitate the production of umbilical cord blood components: neonatal red blood cells (nRBCs), platelet concentrate (nPC), and plasma poor platelets (nPPPs). The bags making up the BioNest system have an optimal volume for the closed-circuit fractioning of cord blood.
The system is divided into two parts: 1) interconnected bags A, B and C; and 2) a separate bag D in which the platelets previously concentrated and stored in bag B are activated in order to obtain the formation of a cord blood platelet gel (CBPG). Bag D has an incision on the side that makes it easy to open by simply tearing off the border, after which the gel can be easily extracted and administered at the patient’s bedside.

The system of interconnected bags A, B and C avoids the need to make costly sterile connections; bag D is supplied separately so that transfusion centres can transfer the frozen platelet concentrates stored in sack B to bag D for thawing and activation by means of a sterile connection (the only connection in the system other than that initially necessary to connect the bag containing cord blood to bag A) when they receive requests for platelet gel from clinical departments.
Finally, bag D of the BioNest system is also available in a multiple configuration of 12 bags interconnected with a tube in order to be able to prepare aliquots of platelet gel from platelets of adult blood donors.

The main advantages of the BioNest system are:
1) The absence of DEHP: the BioNest system does not contain DEHP, one of the phthalate plasticisers that have been associated with potential toxicological and environmental risks. Its safety profile is therefore better than that of DEHP-containing products.
2) The interconnection of bags A, B and C avoids the need to make costly sterile connections between one bag and another, thus reducing the costs and times of blood fractionating procedures, and assuring that the internal circuit is sterile and apyrogenic.
3) All of the bags making up the BioNest system can be frozen to temperatures down to -80 °C.
4) Bag D used to prepare and store the platelet gel has a lateral tear-off opening system that facilitates the extraction of the gel and its therapeutic application at the patient’s bedside.


INTENDED USE
Kifarm®

Polyethylene bag 0.07 mm thick and 104 cm long.
It has a folded 27 cm wide openable end that is useful for positioning; the other end is a narrower (8 cm) graduated cylinder marked from 0 to 1000 cc (+ 50 cc) to collect and approximately quantify the amount of retroplacental blood lost during childbirth.

The medical device “graduated sterile bag for assessing blood loss during childbirth” is a polyethylene bag used to facilitate the collection and approximate quantification of the amount of retroplacental blood lost during childbirth.

INTENDED USE
The device “graduated sterile bag for assessing blood loss during childbirth” is marked CE by the Istituto Superiore di Sanità Notified Body (CE 0373), and manufactured by Meditalia S.r.l, a company with UNI, EN, ISO 9001:2008 and 13485:2003 certifications issued by Kiwa Cermet.
The device “graduated sterile bag for assessing blood loss during childbirth” is only to be used by specialised personnel in the delivery room.
When used, the bag should be removed from its individual packaging and opened at its widest end (identified by a green marker) by manually separating the two sides. It should then be positioned under the buttocks of the woman in labour at the free end of the bed in such a way as to be able to collect the lost retroplacental blood by means of gravity.
Primary packaging made of sealed printed medical paper that allows ethylene oxide (ETO) sterilisation of the device and guarantees the individual packaging of each bag. The final packaging is a box containing 200 individually packaged bags. Each box contains a leaflet with instructions for using the device.
5 years in unopened and undamaged packaging.