last updated : 2018/12/31
Code Description Ind. price Ship. weight Ship. vol.
MINSNEEDJTS01
TRANSFER SET, sterile fluids, short spike, botl.up to 100ml CH 0,14 0,0047kg 3,724L Add
Controlled Temp : Storage +15 to +25°C

General information

Permits the transfer of parenteral medications, and in some instances intravenous (IV) fluids, between one container(s) (e.g., a vial) and another (e.g., an intravenous (IV) bag); it can also be used to reconstitute medication during preparation and for administration.

Specifications

Medical device designed to transfer sterile fluids in a closed system.

 

Materials:

Medical grade plastic, PVC-free.

 

- Double-channelled hollow device, with two short and slim piercing spikes with rounded bevels (reduces the creation of rubber particles during cutting), separated by a disk plate (grip handle).

 

- Protective cap for each spike.

 

- Fits into rubber stoppers of up to 6.3mm in thickness and the set port on a bag; for vials and bottles up to 100ml.

 

- Must ensure a good flow, even with non-evacuated glass vials.

Quality  requirements:

Quality complies with European Medical Device Directive Council directive 93/42/EEC or equivalent.

Unit presentation:

1 unit, sterile, individually peel pack, single use.

Primary packaging:

Labelling: Manufacture’s name and/or trademark, product description and reference number, "sterile" with method, lot number, expiry date by year and month, "for single use", and CE mark and reference number of notifying body. Must be multilingual: English, French and Spanish, others when available.

Secondary packaging:

Protected unit, one (1) box 50-unit presentation, labelling is the same as primary packaging.

 

Additional required information: Number of units per secondary packaging. Information for product-specific storage conditions (e.g., temperature, pressure, light, humidity, etc.).

Transport packaging:

Labelling same as secondary packaging with product-specific transport and storage instructions, and quantity in secondary packaging.