| Specifications of whole blood pack sets. | |||
| ◆ CPDA (Citrate, Phosphate, Dextrose, Adenine) | |||
| or CPD (Citrate, Phosphate, Dextrose ) plus SAG-M Solution (Sodium Chloride, Adenine, Glucose, Mannitol) | |||
| ◆ 250/350/450/500 ml Primary bag containing anticoagulant 63ml CPD solution with a ultra thin walled sharp needle, | |||
| 400ml (Optional 300ml) satellite bags with blood sampling port, blood sampling bag and needle protector | |||
| ◆ Made of high quality medical DEHP PVC sheet material which maintains aerobic metabolism | |||
| ◆ Sterilized by steam in high pressure can assure products non-pyrogen and toxin-free. | |||
| Specifications of needle | |||
| ◆ Tamper proof needle with an indicator that allows one to instantly confirm that the needle protector has not been removed | |||
| ◆ Covered with protective plastic | |||
| ◆ 16-G ultra thin walled sharp needles | |||
| ◆ The needle bevel (< 0.5 cm) is oval split to maximise easy insertion into a donor arm. | |||
| Oval shape allows sufficient needle point that allows sharp entry into a vein. | |||
| Specifications of needle Pilot tube | |||
| ◆ Pilot tube length is 90-120cm( Optional choice as per requirement) | |||
| ◆ Each tube imprinted with a unique pilot tube number for batch tracing | |||
| ◆ No air bubbles in the fluid path | |||
| ◆ Made of flexible and sealable material | |||
| Specifications of bag design | |||
| ◆ Round shaped with round edges, no sharp corners | |||
| ◆ Made of medical grade PVC materials that provide high ventilation with CE certification whilst maintaining in-vivo conditions | |||
| ◆ Leak proof design | |||
| ◆ Simple bend of the connector tube allows blood components to be transferred smoothly into the satellite bags | |||
| ◆ Flow clamps in tube ( 1~ 4 clamps as per requirement) | |||
| ◆ Each bag have hanger slits on every sides for use during collection, processing and transfusion | |||
| ◆ Optional sampling collection pouch and blood collection tube is attached or not as per requirement. | |||
| Specifications of Label design | |||
| ◆ None peel-off even if soaked overnight in water | |||
| ◆ Clearly marked with “sterile, non-pyrogenic and non-toxic” | |||
| ◆ Clearly indicating volume and constituents of anti-coagulant | |||
| ◆ Clearly indicating volume size of blood capacity (450ml) | |||
| ◆ Clearly indicating manufacturing date, expiry date and batch(Lot)No. | |||
| ◆ Clearly indicating manufacturer’s and exporter's name and address. Optional indicating local distributor or importer's name and address details. | |||
| Additive Concentrations (per 100ml) | |
| Citric Acid (Anhydrous) | 0.299 g |
| Sodium Citrate (Dihydrate) | 2.63 g |
| Monobasic Sodium Phosphate (Monohydrate) | 0.222 g |
| Dextrose (Monohydrate) | 2.55 g |
| Water for injection | q.s. 100 ml |
| Citric Acid (Anhydrous) | 0.299 g |
| Sodium Citrate (Dihydrate) | 2.63 g |
| Monobasic Sodium Phosphate (Monohydrate) | 0.222 g |
| Dextrose (Monohydrate) | 3.19 g |
| Adenine | 0.0275 g |
| Water for injection | q.s. 100 ml |
| Dextrose (monohydrate) | 0.900 g |
| Sodium chloride | 0.877 g |
| Adenine | 0.0169 g |
| D-mannitol | 0.525 g |
| Water for injection | q.s. 100 ml |
For human whole blood storage
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