CE Class IIB medical device certification under Directive 93/42/EEC (Annex II, excluding section 4).
Certified by an EU Notified Body (NB 2195) according to distributor information for ONSET PRP tubes.
Manufactured under sterile ISO Class cleanroom conditions (e.g. ISO 7 environment) as described for ONSET PRP tubes.
CE Class IIB medical device certification under Directive 93/42/EEC (Annex II, excluding section 4).
Certified by an EU Notified Body (NB 2195) according to distributor information for ONSET PRP tubes.
Manufactured under sterile ISO Class cleanroom conditions (e.g. ISO 7 environment) as described for ONSET PRP tubes.
Biocompatibility and performance testing performed in line with medical device standards, as stated by distributors.
PRP Tubes (Platelet Rich Plasma Collection)
Description
ONSET PRP Single Tube 10ml is a sterile, single-use 10 ml vacuum blood collection tube prefilled with sodium citrate anticoagulant for the safe and efficient preparation of platelet rich plasma (PRP). Designed as a human-injectable Class IIB CE-marked medical device and manufactured in ISO-class cleanroom conditions, the tube enables reliable PRP separation for a wide range of regenerative and aesthetic procedures, including facial rejuvenation, hair restoration and orthopedic/sports medicine applications.
Bnefits
Dedicated PRP vacuum tube designed specifically for platelet rich plasma preparation rather than generic blood storage.
10 ml tube prefilled with 1 ml high-purity sodium citrate anticoagulant to maintain platelet viability and prevent clotting.
Human injectable tube meeting CE Class IIB requirements and biocompatibility testing for safety.
Manufactured in sterile ISO-class cleanroom conditions for consistent quality and reduced contamination risk.
Compatible with most low-speed PRP centrifuge machines used in aesthetic and regenerative practices.
Supports high-quality PRP yield suitable for facial rejuvenation, hair loss treatment, orthopedic and other regenerative indications.
Biocompatibility and performance testing performed in line with medical device standards, as stated by distributors.
Sterile 10 ml vacuum blood collection tube (human injectable medical device).
Approximately 1 ml sodium citrate anticoagulant solution (around 3.13–3.8% Ph. Eur., as specified for ONSET PRP tubes).
Formulation
Medical device: 10 ml vacuum tube prefilled with sodium citrate anticoagulant for autologous PRP preparation (no added drugs or biologics beyond anticoagulant).
Packaging
Single sterile 10 ml ONSET PRP vacuum tube supplied for professional use.
Tube supplied as part of individual sale units or within ONSET PRP kits (where applicable) for qualified healthcare professionals.
Usage
Use only in a clinical/medical environment by appropriately trained healthcare professionals following local guidelines.
Prepare a clean, sterile workspace and observe aseptic technique; wear appropriate personal protective equipment.
Perform venipuncture and collect the recommended volume of autologous blood directly into the ONSET PRP tube according to local PRP protocol.
Gently invert the tube several times to mix the blood thoroughly with the sodium citrate anticoagulant and prevent clotting.
Place the tube into a compatible PRP centrifuge, ensuring proper balancing with a tube of equal volume or weight.
Centrifuge according to the PRP protocol recommended for ONSET PRP tubes and your centrifuge (speed and time set per clinic SOP).
After centrifugation, identify the PRP layer and, using a sterile syringe or transfer device, carefully extract the PRP without disturbing red blood cell layers.
Use the prepared PRP immediately for the intended treatment (e.g. injections, microneedling, mesotherapy) according to indication-specific protocols.
Dispose of the used tube and sharps as biohazardous waste in accordance with local regulations; the tube is single-use and must not be re-sterilized or reused.
Contraindications
Use of the tube in patients for whom autologous PRP therapy is contraindicated (e.g. significant platelet/bleeding disorders, severe anemia, active systemic infection, certain anticoagulant therapies) as per clinical guidance.
Use in patients with known hypersensitivity or allergy to citrate where clinically relevant.
Use outside of professional medical or aesthetic practice or by untrained personnel.
Re-use or re-sterilisation of the single-use tube.
Adverse Effects
The tube itself is an inert collection device; adverse effects relate to venipuncture (e.g. bruising, hematoma, local discomfort) and to PRP procedures (e.g. pain, swelling, redness, rare infection) rather than the tube when used correctly.
Improper mixing or centrifugation may compromise PRP quality and potentially affect treatment efficacy.
Storage Conditions
Store the tubes in their original packaging in a clean, dry place.
Recommended storage in typical medical device conditions (often around 2–25 °C) away from direct sunlight, moisture and heat sources.
Do not use after the expiry date printed on the packaging.
Avoid freezing or exposing tubes to extreme temperatures or physical damage.
Duration
Device-dependent; PRP treatment protocols typically involve a series of sessions (e.g. 2\u20134 sessions spaced several weeks apart) with aesthetic benefits that may last several months, according to clinical judgement and indication.
Onset
Not applicable to the tube itself; in aesthetic PRP procedures, visible improvements are commonly reported from a few weeks after treatment, depending on indication and patient factors.
