Description

Intended use

Disposable, single‑patient, sterile paediatric endotracheal tube for oral or nasal intubation to maintain airway patency and enable positive pressure ventilation. Suitable for neonatal, infant, and paediatric patients in hospital (OR/ICU), surgical centres, and pre‑hospital/emergency care. Single patient use only; do not use for more than 28 days.

Configurations

• Oral/Nasal Magill style
• Oral Curved (RAE) also available

Key features

• MICROCUFF high‑volume, low‑pressure, micro‑thin polyurethane cuff; short cylindrical cuff positioned near the tip for reliable distal tracheal sealing.
• Supplied without a Murphy eye to facilitate distal cuff placement.
• Placement aids: centimetre depth markings, black intubation depth mark above the cuff for vocal‑cord alignment, and four precision bands to support confirmation of correct placement.
• Radiopaque line for fluoroscopic/CT visibility.
• Standard 15 mm O.D. connector; cuff inflation via luer‑tip syringe.
• DEHP‑free, latex‑free, BPA‑free; REACH compliant; contains no 3TG conflict minerals and no human/animal‑derived materials.
• Contraindicated near laser or electrosurgical active electrodes due to combustion risk in oxygen‑enriched environments.

Materials and construction

• Main tube: PVC; cuff: polyurethane (PU).
• Opaque/radiopaque line, inflation line, pilot balloon: PVC.
• Valve assembly: PVC, polypropylene (PP), silicone, stainless steel, ABS.
• Connector: polypropylene homopolymer (PPH).

Sizes and selection (Oral/Nasal Magill)

• Range: ID 3.0–7.0 mm; OD 4.2–9.3 mm; length 170–305 mm (all lengths ±5 mm). ID/OD tolerance ±0.15–0.2 mm.
• Age guidance: 3.0 (term ≥3 kg to <8 months), 3.5 (8 months to <2 years), 4.0 (2 to <4 years), 4.5 (4 to <6 years), 5.0 (6 to <8 years), 5.5 (8 to <10 years), 6.0 (10 to <12 years), 6.5 (12 to <14 years), 7.0 (14 to <16 years). Not recommended for infants <3 kg.

Sterility, packaging, storage, disposal

• Ethylene oxide sterilized; sterile, single use; individually packed in Tyvek pouch; boxes of 10.
• Shelf life: 2 years (unopened, per labeling).
• Store in cool, dry conditions; protect from moisture/heat; avoid UV/sunlight/fluorescent light; prevent crushing.
• Dispose after use per facility policy.

Regulatory and manufacturer

• Legal manufacturer: Well Lead Medical, Ltd. (manufactured for AirLife); country of origin: China.
• US: Class II, FDA product code BTR. EU: Class IIa (Rule 5), CE 0123. Australia: Class IIb. Canada: Class II (Rule 2).
• Classification identifiers: EMDN R0103/R010302/R01030201; GMDN 46967; UMDNS 14085; UNSPSC 42271903.

MR safety (MR Conditional)

• Static field 1.5 T or 3 T; max spatial gradient 14 T/m (1400 Gauss/cm).
• RF conditions: CP; permitted coils: whole‑body transmit or head transmit‑receive.
• SAR limits: whole body 2.0 W/kg (normal operating mode); head 3.2 W/kg (normal operating mode); up to 60 minutes continuous RF exposure at 2.0 W/kg whole‑body average SAR.
• May produce approximately 57 mm image artifact. If a parameter is not listed, no conditions are associated with that parameter.

Use notes

• Inflate cuff only to achieve an effective seal; do not exceed 20 cm H2O cuff pressure; monitor continuously.
• For oral or nasal intubation in controlled or emergency settings; confirm position clinically and by imaging as appropriate.
• Single‑patient, single‑use device; do not resterilize or reuse.