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Description
The Avanos MIC-KEY Over-the-Wire (OTW) Stoma Measuring Device is a sterile, single-use tool designed to determine stoma tract length—the distance from the internal cavity wall to the skin surface—to guide selection of the appropriate MIC-KEY low-profile feeding tube shaft length (G-, J-, or GJ-Tube). For use by healthcare professionals; prescription use (Rx) only.
Intended Use
- Measures stoma tract length to support accurate tube sizing and placement planning
- OTW measurement technique enables use with a guidewire when clinically indicated
Key Design and Features
- Over-the-wire configuration with two proximal ports: balloon inflation valve and guidewire/OTW port
- Bi-lumen tubing with printed depth markings from 1.0 to 5.0 cm in 0.25 cm increments for precise reading
- Radiopaque tubing (barium sulfate) for visibility under imaging
- Recessed-tip silicone balloon molded at the distal end; recommended inflation volume 3 mL water per IFU
- External collar/disc provides a clear skin-level reference point for measurement
Specifications
- Overall device length: 18 cm
- Bi-lumen tubing outer diameter: 0.4 cm
- Collar outer diameter: 1.8 cm
Materials and Biocompatibility
- Materials: Silicone, Polyether imide (PEI), Polycarbonate, Barium sulfate
- Not made with natural rubber latex; does not contain DEHP, DBP, or BBP
Sterility and Reusability
- Ethylene oxide (EtO) sterilized
- Sterile, single-use only; do not reuse, reprocess, or re-sterilize
- Use solely to measure stoma tract length
Packaging
- Each device is individually packaged sterile in a Tyvek pouch
- 10 individually packaged devices per carton/case
- Barcoded on unit and shipping case
- Kit includes a 12 mL Luer slip syringe
Manufacturing and Regulatory
- Manufactured in Mexico at an ISO 13485–compliant site
- CE marked under 93/42/EEC; EU Class Im (sterile, measuring)
- Notified Body: BSI (2797)
Storage and Shelf Life
- Store in a cool, dry place away from heat; keep in shipper carton when practicable
- Shelf life: 3 years from date of manufacture
