Description

The MICROCUFF Paediatric Endotracheal Tube (ETT) is a single‑use, sterile cuffed tube designed for oral or nasal intubation in neonatal, infant, and pediatric patients to maintain airway patency and enable positive‑pressure ventilation during anesthesia, resuscitation, or when ventilation is inadequate. The line is marketed by Avanos (MICROCUFF Paediatric Endotracheal Tube) and, in certain markets, by AirLife (EU MDR‑labeled AirLife MICROCUFF Pediatric Oral/Nasal Magill; manufactured by Well Lead Medical, Ltd for AirLife). Size selection and use are based on patient anatomy and clinician judgment.

Design and features

• High‑volume, low‑pressure micro‑thin polyurethane cuff (~10 μm), short cylindrical design positioned distally to seal below the subglottis.
• Tube supplied without a Murphy eye to support distal cuff placement.
• Black vocal cord placement marker; four precision placement/verification bands and centimeter depth markings.
• Continuous radiopaque line for X‑ray visualization.
• 15 mm O.D. universal connector.
• Cuff material designed to seal at lower pressures than conventional pediatric cuffs; design testing withstood burst pressures >800 cm H2O.

Configurations and sizes

• Styles: Oral/Nasal Magill; Oral Curved (RAE).
• Inner diameter options (mm): Magill 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0; RAE 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5.
• Approximate dimensional ranges across sizes: outer diameters ~4.2–9.3 mm; overall lengths ~170–305 mm.
• Approximate tracheal diameter compatibility across the range: ~6.0–11.8 mm.

Materials and biocompatibility

• Tube, opaque line, inflation line, pilot balloon: PVC; cuff: polyurethane (PU); valve: PVC/PP/silicone/stainless steel/ABS; connector: PP/PPH.
• Gas pathway device per EN ISO 18562‑1:2020.
• Not made with DEHP, natural rubber latex, or BPA; REACH compliant; no 3TG conflict minerals; no human/animal‑derived materials.

Sterility, shelf life, and packaging

• Sterilized with ethylene oxide (EtO); individually packaged (e.g., Tyvek pouch).
• Common pack-out: 10 per box; may be case‑packed.
• Shelf life: 2 years unopened (per labeling).
• Store in a cool, dry place; protect from moisture, excessive heat, and UV/sun/fluorescent light; store to prevent crushing.

MR safety (MR Conditional)

• Static magnetic field: 1.5 T or 3 T; maximum spatial field gradient: 14 T/m (1400 Gauss/cm).
• RF: CP excitation; whole‑body transmit coil or head transmit‑receive coil.
• SAR limits (Normal Operating Mode): whole body 2.0 W/kg up to 60 minutes continuous; head 3.2 W/kg.
• May produce ~57 mm image artifact (sequence‑dependent).

Contraindications and precautions

• Do not use during procedures with an active laser beam or an electrosurgical active electrode in the immediate area in oxygen‑enriched environments due to combustion risk and potential toxic/corrosive byproducts (e.g., hydrogen chloride).

Regulatory classification and coding

• USA: Class II, FDA product code BTR; EU: Class IIa (Rule 5), CE 0123; Australia: Class IIb; Canada: Class II (Rule 2). EMDN R0103; R010302; R01030201. GMDN 46967. UMDNS 14085. UNSPSC 42271903.

Use duration and disposal

• Single use; should not remain in situ longer than 28 days.
• Dispose per facility policy after use.