Description

Intended use

• Skin-level, low-profile, balloon-retained gastrostomy button for delivery of enteral nutrition, medication, and gastric decompression. Suitable for pediatric and adult patients requiring long-term gastric access. May be placed initially or used as a replacement in a mature tract per clinical judgment.

Design and features

• Low-profile external base with ENFit-compatible feeding port and attached cap
• Internal silicone retention balloon inflated via balloon valve using a Luer-slip syringe
• Anti-reflux valve opens only when a MIC-KEY extension set is connected; do not feed/flush directly through the port
• Tapered distal tip; recessed at recommended balloon fill volume
• Medical-grade silicone tube with barium sulfate radiopaque stripe
• SECUR-LOK interface for MIC-KEY extension sets
• Not made with natural rubber latex; DEHP-free

Sizes and balloon volumes

• French sizes: 12, 14, 16, 18, 20, 24 Fr
• Stoma lengths (cm): 0.8, 1.0, 1.2, 1.5, 1.7, 2.0, 2.3, 2.5, 2.7, 3.0, 3.5, 4.0, 4.5, 5.0
• Balloon fill (sterile/distilled water only): 12 Fr—3 mL recommended (max 5 mL); 14–24 Fr—5 mL recommended (max 10 mL)

Kit contents (ENFit configuration)

• 1 MIC-KEY Low-Profile G-tube (button)
• 1 Continuous Feed Extension Set, 12 in (30 cm), SECUR-LOK right-angle patient-end; Y-connector with medication port; ENFit connectors; clamp
• 1 Bolus Extension Set, 12 in (30 cm), SECUR-LOK straight patient-end; ENFit connector; clamp
• 1 × 6 mL Luer-slip syringe (balloon inflation/deflation)
• 1 × 35 mL ENFit enteral syringe
• Gauze pads
• Insertion stylet and water-soluble lubricant may be included depending on region; stoma measuring device not included

Extension sets and compatibility

• Use only MIC-KEY extension sets with the MIC-KEY feeding port
• Replacement lengths available: 30 cm and 60 cm (continuous and bolus configurations as described above)
• Extension sets are non-sterile, single-patient reusable, natural rubber latex-free, and DEHP-free

Materials, sterility, and reuse

• G-tube/button: medical-grade silicone; barium sulfate stripe; internal components include polyether imide, polycarbonate, and a stainless steel spring
• Extension sets: PVC (citrate-softened) tubing; ABS connectors; polypropylene clamp
• G-tube is sterile (EtO); single-use only. Extension sets are non-sterile and reusable for one patient

Regulatory, MRI, and manufacturing

• Manufactured in Mexico at an ISO 13485–compliant site
• CE marked under 93/42/EEC, Class IIb (Notified Body BSI, CE 2797)
• MR Conditional at 1.5 T and 3 T when used as labeled

Packaging, storage, and shelf life

• Individual sterile hard tray; 1 tray per carton (approx. 25.9 × 18.7 × 5.1 cm; 431 g)
• Store in a cool, dry place away from heat and radiation; keep in dispenser box when possible
• Shelf life: 2 years from date of manufacture

Notes

• This listing is for the MIC-KEY G (gastrostomy) button with ENFit extension sets; it does not include a jejunal limb or GJ capabilities
• Indications include long-term enteral nutrition, medication delivery, and gastric decompression; contraindications include ascites, colonic interposition, portal hypertension, peritonitis, and morbid obesity—follow the full IFU/clinical judgment