Consumables, CPAP,6mos,Diamedica,Hudson

GENERAL DESCRIPTION
Consumables bundle for the Diamedica CPAP 20. Bundle is for one CPAP device for an estimated 6 months of use, assuming a 5-day patient stay. This bundle contains Hudson-style nasal cannulas to support neonatal CPAP patients with weights ranging from less than 700 grams to greater than 3000 grams.

TECHNICAL SPECIFICATIONS
8 x Bubble CPAP set, silicone cannula prongs – Size 0 (016-001-000)
28 x Bubble CPAP set, silicone cannula prongs – Size 1 (016-001-001)
7 x Silicone prong – Size 2 (016-012-002)
7 x Silicone prong – Size 3 (016-012-003)
7 x Silicone prong – Size 4 (016-012-004)
7 x Silicone prong – Size 5 (016-012-005)
1 x Silicone prong – Size 6 (016-012-006)
1 x Silicone prong – Size 7 (016-012-007)
2 x Silicone tube, autoclavable (002-002-3150E)
72 x Straight connector 15M/11.5 – 10M, single use (1661000)
36 x Straight elastomeric connector, single use (1702000)
36 x Bubble PAP valve bottle, single use (AN0018)
1 x Humidifier bottle, autoclavable (H110)
1 x Intake bacteria filter (1025D-605)
1 x Cabinet air filter (303DZ-605)

STORAGE CONDITIONS
Temperature: store within -10 to 40°C (range varies per component)
Relative humidity: keep dry

WARRANTY
Includes 2-year standard warranty, dated from the completion of the terms of delivery.

SHELF LIFE
5 years (from date of manufacture of individual components)

WEIGHT/VOLUME
2 cartons
Total weight: 14.5kg (6.5kg + 8kg)
Volume (m³): 0.152m³ (0.066m³ + 0.086m³)

QUALITY MANAGEMENT SYSTEM
- Manufacturer is certified for ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes.
- Supplier (if not the manufacturer) at a minimum is certified for ISO 9001 Quality management systems – Requirements.

REGULATION & CONFORMITY REQUIREMENTS
Medical consumables have CE certificate under EU MDD 93/42/ECC or EU MDR 2017/745.