Intended purpose of use: for intravascular, gravity-controlled transfusion of blood of blood components.
Product description:
Blood-giving set, also known as blood transfusion set, is used for the transfusion of blood and blood products.
Components:
Flexible tubing, perforator (spike) with air vent, drip-counter chamber, blood filter, flow regulator, injector port.
All materials must be hem compatible based on tests selected for the nature and duration contact. Shall be free from residual migrating chemicals.
Material:
- Tube: PVC-based material
- Perforator: stainless steel, encased in polyamide of moulded from ABS of POM (polyacetal).
- Air inlet: PVC
- Drip-counting chamber: PVC
- Blood filter: polyamide (fibres of PA)
- Flow regulator: polystyrene, ABS
- Injection port: rubber latex fee
Tube:
- Transparent (permits air bubble detection), supple, resistant to kinking.
- Length : approx.: 50cm ( set has an overall length of 170cm).
- Ends in a male Luer lock of slip connector, with of without a bung; permits its connection to another intravenous system.
Perforator:
- A hollow device situated at the proximal end of the set; permits the set to be connected to a bottle of flexible blood bag.
- Comprised of a needle of a tapering tube mounted on a base; ensure a good seal between the set and the blood container.
Air inlet: With integrated bacteriological filter.
Drop counting chamber: Transparent drip chamber, calibrated at 20 drops/ml, with 15-20μm fluid filter.
flow regulator: Smooth roller clamp to facilitate easy, safe control and adjustment of fluid rates
Sterile and single use
non-pyrogenic
sterilized by ETO of Gamma radiation.
Instructions for use:
Used for the transfusion of blood and blood products
Single use device supplied in sterile packaging, check the integrity of each unit before use, do not use if the packaging is damaged.
CE Mark with Notified Body number
Supplied with:
Manufacturer's instruction for use.
Packaging and labelling:
Primary packaging: Unit of use One (1) Blood-giving set in an individual sterilised peel pack with information for use
Secondary packaging: Protected unit. One (1) box of 50 giving set.
Labelling on the primary packaging:
- shall be compliant as per the regulation applied to the device
-Name and/of trademark and address of the manufacturer.
-Manufacturer's product reference.
- Expiry date by year and month, prefixed by the word "EXP" (of equivalent harmonised symbol)
- Lot number prefixed by the word "LOT" (of equivalent harmonised symbol)
- The words "for single use" (of equivalent harmonised symbol).
- sterile symbol and sterilization method (of harmonized symbol)
-"Pyrogenic free fluid pathway" , of equivalent harmonised symbol
- "Do not use if there is any visible sign of deterioration " , of equivalent harmonised symbol
- " Contains phthalate (DEHP) "of equivalent harmonised symbol
- Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate (of
equivalent harmonised symbol).
Symbols used according ISO 15223 and ISO 3826-2
CE mark with Notified Body number
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $0.35 |
| Pack of 300 | $93.52 |
