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PRP Pure Kit

PRP Pure Kit

PRP PURE

Medical device – PRP preparation kit
  • CE Marked Class II medical device for preparation of autologous PRP.
  • Produced in the United Kingdom in compliance with applicable UK/EU medical device regulations.
  • Single Use, sterile, closed system designed to minimise contamination risk and support safe clinical practice.
  • PRP output specifications: RBC < 1%, platelet harvestation > 94%, leucocytes < 4% when used according to the manufacturer’s protocol.
Class II platelet-rich plasma (PRP) preparation kit \u2013 closed, additive-free system

Description

The PRP Pure Kit is a CE-marked Class II medical device designed for the preparation of pure autologous platelet-rich plasma (PRP) using a simple, one-stage closed system. Produced in the United Kingdom, it is the only UK-manufactured PRP kit on the market and is engineered to deliver high-quality, homogenous PRP without the use of additives, activators or separation gel, minimising the risk of intolerance or allergic reactions. Each kit contains six sterile 10 ml PRP tubes pre-loaded with sodium citrate anticoagulant, along with individually sterilised syringes, needles and a phlebotomy set, providing everything required for blood collection, centrifugation and PRP harvesting for up to six treatment sessions. The system consistently yields PRP with red blood cells (RBC) < 1%, platelet harvestation > 94% and leucocytes < 4%, supporting effective PRP therapy in aesthetic, dermatologic, orthopaedic and regenerative medicine settings when used by appropriately trained healthcare professionals.

Bnefits

  • Pure autologous PRP preparation with no additives, activators or separation gel, reducing risk of intolerance or allergic reaction.
  • UK-produced, CE-marked Class II medical device ensuring traceability and compliance with European/UK medical device regulations.
  • Closed, one-stage system that is simple to perform and helps reduce contamination risk compared with multi-step open systems.
  • High-quality PRP yield with RBC < 1%, platelet harvestation > 94% and leucocytes < 4%, providing a concentrated, homogenous PRP sample.
  • Cost-effective kit format with six 10 ml tubes per box, enabling up to six PRP treatment sessions from a single kit.
  • Individually sterile, vacuum-sealed tubes with 1 ml sodium citrate anticoagulant for consistent, reproducible blood collection.
  • Comprehensive kit including syringes, needles and phlebotomy accessories, so no additional disposables are required apart from standard PPE and a compatible centrifuge.
  • Single-use, sterile components designed for patient safety and straightforward disposal after use.

Indications

  • Preparation of pure autologous platelet-rich plasma (PRP) from peripheral venous blood for use in medical and aesthetic procedures by qualified practitioners.
  • Use in aesthetic and dermatologic PRP applications (e.g. skin rejuvenation, fine lines, acne scarring, skin quality improvement) according to local clinical protocols.
  • Use in scalp and hair restoration PRP procedures (e.g. androgenetic alopecia) when clinically indicated.
  • Use in musculoskeletal and orthopaedic PRP treatments (e.g. tendinopathy, joint degeneration) as part of a wider treatment plan, where permitted by local regulation.
  • Use in other approved regenerative medicine protocols where autologous PRP preparation from whole blood is required and compatible with a pure, gel-free PRP system.

Composition

  • 6 x 10 ml PRP tubes (European tubes) each vacuum-sealed and pre-filled with 1 ml sodium citrate anticoagulant.
  • Tubes do not contain activators or separation gel; non-haemolytic design to minimise platelet loss during centrifugation.
  • 6 x 2.5 ml individually sterilised syringes for PRP transfer and injection preparation.
  • 6 x 21G 80 mm long needles for aspirating PRP from the tubes after centrifugation.
  • 6 x 18G 40 mm needles used as air filters to release tube vacuum safely.
  • 6 x 30G 13 mm injecting needles for intradermal / subcutaneous PRP delivery (final injection needle choice may be tailored by the practitioner).
  • 6 x tube holders (vacutainer-style) for venous blood collection.
  • 6 x 21G / 23G flashback needles / butterfly sets for venepuncture and blood draw.

Formulation

  • Closed PRP preparation system comprising vacuum blood collection tubes with sodium citrate anticoagulant and accessory disposables.
  • Pure autologous PRP system with no additives, no exogenous activators and no separation gel.
  • Designed to produce 4–6 ml of homogenous PRP per 10 ml tube after centrifugation, depending on haematocrit and protocol.
  • Single-use, sterile components intended for one patient only.

Packaging

  • Boxed kit containing 6 x 10 ml CE-marked Class II PRP tubes manufactured in Europe for PRP PURE.
  • Accessory pack including 6 x 2.5 ml syringes, 6 x 21G 80 mm aspiration needles, 6 x 18G 40 mm air-release needles, 6 x 30G 13 mm injection needles, 6 x tube holders and 6 x 21G / 23G butterfly needles.
  • Supplied as a sealed, sterile, single-use kit for up to six PRP treatment sessions (one tube per treatment in typical protocols).
  • Labelling indicating UK production, CE mark, Class II medical device status and lot/expiry information for traceability.

Usage

  • For professional use only; the kit may only be used by licensed healthcare professionals or qualified aesthetic practitioners trained in PRP techniques and phlebotomy.
  • Prepare the patient and obtain informed consent according to local clinical and legal requirements for PRP therapy.
  • Using the supplied tube holder and butterfly needle, draw venous blood directly into a PRP Pure tube; each 10 ml tube is pre-vacuumed and contains 1 ml sodium citrate anticoagulant. Gently invert the tube several times to mix blood with anticoagulant, avoiding vigorous shaking.
  • Fill the required number of tubes according to the treatment protocol, typically one tube per standard PRP treatment area or session.
  • Place the filled tubes into a compatible centrifuge according to the manufacturer’s recommended settings (speed and time) for PRP Pure tubes; balance the centrifuge appropriately before spinning.
  • After centrifugation, carefully insert the 18G needle into the tube to release vacuum (air filter function) if required, then use the 21G 80 mm long needle attached to a sterile 2.5 ml syringe to aspirate the PRP layer, avoiding the red blood cell fraction.
  • Transfer the harvested PRP into injection syringes and attach the appropriate injection needle (e.g. 30G 13 mm) as per the clinical protocol and treatment area.
  • Administer PRP according to institutional guidelines and established PRP techniques (e.g. nappage, mesotherapy-style injections, intra-articular injection), observing strict aseptic technique at all times.
  • Dispose of all used tubes, needles and syringes as clinical sharps waste in accordance with local regulations; the kit is single-use and must not be reused.
  • Always follow the official PRP PURE kit instructions for use (IFU) and local clinical protocols for centrifuge settings, tube handling and injection technique.

Contraindications

  • The kit itself has no direct therapeutic action; contraindications relate to PRP blood collection and injection procedures.
  • Known hypersensitivity or contraindication to autologous blood-derived products or any material in the kit (e.g. latex in ancillary components, where applicable).
  • Patients with significant coagulopathies, platelet dysfunction syndromes or very low platelet counts, where PRP preparation may be unsafe or ineffective.
  • Ongoing anticoagulant or antiplatelet therapy where the risk of bleeding or haematoma is considered unacceptable by the clinician.
  • Active systemic infection, local infection at the intended injection site, or uncontrolled chronic infection.
  • Uncontrolled severe systemic disease (e.g. decompensated cardiovascular, hepatic or renal disease) where PRP procedures are contraindicated by the treating physician.
  • Known haematologic or oncologic disorders where PRP therapy is not recommended by current guidelines or the treating specialist.
  • Pregnancy and breastfeeding, unless a suitably qualified clinician judges PRP treatment appropriate within local regulations.
  • Any other general contraindication to PRP treatment established by local protocols or regulatory guidance.

Adverse Effects

  • Adverse events are those typically associated with venepuncture and PRP injection procedures, not the kit materials themselves.
  • Local pain, bruising or haematoma at blood-draw or injection sites.
  • Transient swelling, erythema, tenderness or discomfort in treatment areas following PRP injection.
  • Infection at the injection site if aseptic technique is not strictly observed.
  • Very rare risk of vascular or nerve injury, particularly with deep or intra-articular injections performed using inappropriate technique.
  • Dizziness or vasovagal reactions related to blood draw or injections.
  • Inadequate PRP yield or quality if centrifugation or handling instructions are not followed, potentially reducing treatment efficacy.

Storage Conditions

  • Store the unopened kit in a clean, dry environment at controlled room temperature as specified in the product labelling (typically around 15–25 °C).
  • Protect from direct sunlight, excessive heat and freezing conditions.
  • Keep all components in their original sterile packaging until use to maintain sterility.
  • Do not use tubes or accessories past the expiry date or if sterile packaging is damaged or opened.
  • Store out of reach of unauthorised persons and children; for professional use only.

Duration

Each PRP Pure Kit provides up to six individual PRP treatment sessions (one 10 ml tube per session) depending on the clinical protocol. The duration of benefit from each PRP treatment is determined by the specific indication (e.g. aesthetics, hair restoration, orthopaedics) and typically ranges from several months to over a year; treatment schedules (e.g. 3\u20134 sessions spaced weeks apart with maintenance treatments) are set by the treating clinician.

Onset

The kit enables immediate preparation of injectable PRP at the point of care; once blood is drawn and centrifuged, PRP is usually ready for use within a short time frame (often 10\u201320 minutes depending on centrifuge protocol). Clinical onset of effect (e.g. symptom relief or skin/hair improvement) depends on the indication and patient factors and generally evolves over weeks following a PRP treatment course.

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