PharmaHelpBag - Medical Dispensing Systems
Transcription
PharmaHelpBag - Medical Dispensing Systems
Medical Dispensing Systems B.V. Kopersteden 24/5 NL-7547 TK ENSCHEDE +31 (0)53 450 09 49 +31 (0)84 224 80 99 info@medicaldispensing.nl www.medicaldispensing.nl PharmaHelpBag Through E-mail From Peter Kars Attn. To whom it may concern Date May 5th, 2014 E-mail kars@medicaldispensing.nl Phone E-mail Final product 1 empty IV bag in a softblister, which is sealed, stamped, put in an outer box (75 softblisters per box; box dimensions: 29 x 27 x 24 cm), and sterilized. Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl Medical Dispensing Systems B.V. Bank: 3133.60.499 – Rabobank Hengelo VAT ID: NL817123799B01 Chamber of Commerce no: 08100685 – Enschede IBAN: NL86RABO0313360499; BIC: RABONL2U Page 1 of 3 Use – – – The PharmaHelpBag is to be used with the PharmaHelp compounder. The PharmaHelpBag is used for taking up carrier solution from infusion bags. The PharmaHelpBag is sterilized as the PharmaNeedle is in contact with the ports of the PharmaHelpBag and so with the final patient drug container. Contraindications / warnings – – The PharmaHelpBag is not intended to carry medication / drugs to be delivered to a patient. The PharmaHelpBag is not CE-certified. Bag The bags are made of multi-layer polyolefin film. Sterilization method The sterilization method is γ-irradiation using the VDmax method. A typical dose is 25 kGy. Nominal capacity The nominal capacity is 300 mℓ. Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl Medical Dispensing Systems B.V. Bank: 3133.60.499 – Rabobank Hengelo VAT ID: NL817123799B01 Chamber of Commerce no: 08100685 – Enschede IBAN: NL86RABO0313360499; BIC: RABONL2U Page 2 of 3 Bioburden The bioburden – defined as the total of aerobic bacteria, yeast, and moulds – is equal to 40. This is small, thus enabling the VDmax method. Risk management Not applicable. The employees of hospital pharmacies / compounding centres are already acquainted with working with (empty) IV bags. Shelf life 3 years from sterilization date, which is August 2013. Our conditions of sale and delivery apply to all our deliveries and can be downloaded from our website: www.medicaldispensing.nl Medical Dispensing Systems B.V. Bank: 3133.60.499 – Rabobank Hengelo VAT ID: NL817123799B01 Chamber of Commerce no: 08100685 – Enschede IBAN: NL86RABO0313360499; BIC: RABONL2U Page 3 of 3