Medical device – sterile single-use pen needle for subcutaneous injection
34G 4 mm pen needle for insulin and human growth hormone injection pens
Certifications
CE Certified medical device: CE 0197, with TÜV Rheinland LGA Products GmbH, Germany, listed as the notified body in manufacturer documentation.
Radiation Sterilised with a sterility assurance level (SAL) of at least 10⁻⁶, as stated in the manufacturer’s regulatory and quality information.
Manufactured in compliance with applicable ISO standards and pharmacopoeia requirements relevant to sterile hypodermic/pen needles (specific standard numbers are not detailed in the cited product page).
CE Certified medical device: CE 0197, with TÜV Rheinland LGA Products GmbH, Germany, listed as the notified body in manufacturer documentation.
Radiation Sterilised with a sterility assurance level (SAL) of at least 10⁻⁶, as stated in the manufacturer’s regulatory and quality information.
Manufactured in compliance with applicable ISO standards and pharmacopoeia requirements relevant to sterile hypodermic/pen needles (specific standard numbers are not detailed in the cited product page).
Labelled as a sterile, single Use medical device with standard device symbols for non Reuse, irradiation sterilisation, batch code, catalogue number, use By date, and manufacturer/EC representative information.
Description
Nanopass 34G Needle for Pen Injectors is a sterile, single-use, 34-gauge, 4 mm pen needle designed for use with pen injector devices for the subcutaneous injection of drugs, including insulin and human growth hormone. The needle features Terumo’s patented double-tapered design and asymmetric bevel, making it one of the world’s thinnest double-tapered pen needles (34G) and engineered to reduce injection pain while maintaining adequate drug flow. It is supplied as individually packed pen needles in an ergonomic plastic case, intended for use in diabetes care and other chronic conditions requiring frequent subcutaneous injections. Each box contains 100 needles and the device is CE-certified (CE 0197) and sterilised by irradiation.
Bnefits
World’s thinnest double-tapered pen needle in 34G, designed to decrease the probability of contacting cutaneous pain receptors.
Asymmetric needle bevel that is designed to cut the skin rather than puncture it, aiming to reduce penetration resistance and pain during insertion.
Slim double-tapered needle shape engineered to provide better flow and require less injection force than comparable 32G pen needles.
34G needle (approximately 0.18 mm outer diameter) with 4 mm length, suitable for subcutaneous injections with common insulin and growth hormone pens.
Individually packed, ergonomically cased pen needles to support safe handling and automated assembly in clinical and home-care settings.
Radiation-sterilised with a sterility assurance level of at least 10⁻⁶ and manufactured in compliance with applicable ISO standards and pharmacopoeia requirements.
Device contains no components made of natural rubber latex, which helps reduce the risk of latex-related reactions in sensitive users.
Compatible with most common pen injector devices (per manufacturer information; specific compatibility lists are provided on Nanopass pen needle packaging).
Indications
Intended for use with a pen injector device for the subcutaneous injection of drugs, including insulin and human growth hormone, as stated in the manufacturer’s instructions for use.
Use in diabetes care for subcutaneous administration of insulin when prescribed with compatible insulin pens.
Labelled as a sterile, single Use medical device with standard device symbols for non Reuse, irradiation sterilisation, batch code, catalogue number, use By date, and manufacturer/EC representative information.
Manufacturer (Terumo Corporation) and European representative (Terumo Europe N.V., Interleuvenlaan 40, 3001 Leuven, Belgium) identified in the instructions for use and corporate materials.
Medisave UK Ltd, the referenced retailer, states registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a wholesaler/distributor and certification to ISO 9001 (quality management) and ISO 14001 (environmental management).
Manufacturer (Terumo Corporation) and European representative (Terumo Europe N.V., Interleuvenlaan 40, 3001 Leuven, Belgium) identified in the instructions for use and corporate materials.
Medisave UK Ltd, the referenced retailer, states registration with the UK Medicines and Healthcare products Regulatory Agency (MHRA) as a wholesaler/distributor and certification to ISO 9001 (quality management) and ISO 14001 (environmental management).
34G 4 mm pen needle for insulin and human growth hormone injection pens
Use for subcutaneous administration of human growth hormone and other compatible subcutaneous injectable medications via pen injector systems, as directed by a healthcare professional.
Composition
Needle material: stainless steel X5CrNi 18-10 (austenitic stainless steel) as specified in the manufacturer’s general specifications.
Hub material: polypropylene, as stated in the manufacturer’s general specifications.
Individual packaging: polypropylene with seal, as listed in the general specifications.
No components made of natural rubber latex, as explicitly stated in the instructions for use.
Sterilisation method: irradiation (radiation sterilisation) with a sterility assurance level of at least 10⁻⁶, according to manufacturer information.
Formulation
Device type: sterile, single-use, non-pyrogenic pen needle for subcutaneous injection via pen injectors.
Needle tip diameter: 34G (approximately 0.18 mm), per manufacturer general specifications.
Needle length: 4 mm, as specified by the manufacturer.
Needle design: double-tapered, slim wall design intended to provide improved flow characteristics compared with conventional 32G pen needles.
Needle tip: asymmetric bevel designed to cut the skin instead of puncturing it, with the aim of reducing penetration resistance and perceived pain.
Pen-injector compatibility: configured to fit most common pen injectors; specific compatible devices are listed on Nanopass pen needle boxes (per manufacturer guidance).
Packaging
Commercial pack size: box of 100 pen needles, as stated in manufacturer general specifications and retailer listings.
Each pen needle is individually packed and sealed in a plastic case with a protective seal to maintain sterility until opening.
Outer sales carton labelled as Nanopass 34G (4 mm pen needles), including CE mark (CE 0197), lot number, use-by date, and relevant device symbols as per the instructions for use.
Packaging and labelling indicate that the device is sterile by irradiation, single-use only, and free of natural rubber latex.
Usage
Use only with compatible pen injector devices and only as instructed by a physician or qualified healthcare professional, as stated in the manufacturer’s instructions for use.
Check that the protective seal on the individual needle pack is intact; do not use if the seal is open or damaged.
Immediately after opening the protective seal, attach the needle straight onto the pen injector and screw clockwise until it is firmly in place.
Remove the outer and inner needle caps with a straight pulling motion, taking care not to touch the needle directly.
Before each injection, perform an air shot (priming) according to the pen manufacturer’s instructions and confirm that medication flows through the needle tip.
Disinfect the injection site prior to each injection and inject vertically into the skin, ensuring subcutaneous placement according to clinical guidance.
Maintain the needle position during drug administration and then withdraw the needle straight out from the skin after injection is complete.
After use, remove the needle from the pen by unscrewing it counter-clockwise while holding the pen firmly.
Dispose of the used needle immediately in an appropriate sharps container; the product is strictly single-use and must not be reused, re-sterilised, or reprocessed.
Do not leave the needle attached to the pen injector between injections to reduce the risk of needle-stick injury, air entering the cartridge, or needle blockage.
Contraindications
Not publicly listed (the manufacturer’s publicly available information and instructions for use do not specify formal medical contraindications beyond standard precautions for use of subcutaneous injection needles and adherence to professional medical advice).
Adverse Effects
Not publicly listed as a formal adverse-effect profile in the same way as medicinal products; however, the instructions for use highlight general risks associated with pen needles such as:
Risk of infection or compromised sterility if the needle is reused, reprocessed, or re-sterilised, which can affect sterility, biocompatibility, and functional integrity of the device.
Risk of needle-stick injuries to users or others if used needles are not handled and disposed of safely in appropriate sharps containers.
Risk of needle bending or breakage if the needle is damaged, if the insertion angle is changed while the needle is inserted, or if it is mishandled; users are instructed to contact a physician immediately if a broken needle remains in the body.
Risk of leakage of medication at the injection site and potential for injection into the dermis rather than subcutaneous tissue if the technique is incorrect, as noted in the instructions for use.
Users are advised to follow healthcare professional instructions and device IFU carefully to minimise these risks.
Storage Conditions
Avoid exposure to water and direct sunlight during storage, as specified in the manufacturer’s instructions for use.
Avoid extreme temperatures and humidity during storage; store in a dry environment within the temperature range indicated on the device packaging (specific numerical ranges are not publicly listed in the referenced material).
Keep out of the reach of children, according to the instructions for use.
Store needles in their original packaging until use to maintain sterility.
Shelf life: 5 years, as stated in the manufacturer’s general specifications for Nanopass 34G pen needles.
Duration
Not publicly listed (device is used for individual subcutaneous injections according to the prescribed medication regimen; no specific treatment duration is defined in manufacturer information).
Onset
Not publicly listed (the device is a delivery system; onset of effect depends on the medication administered, not on the needle itself).
