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Applied Medical Technology 4-5000 - AMT Introducer (Blue "golf tee"), Clamp, Soft Plastic Stiffening Stylet, 10/BX
What is the AMT Introducer?
The AMT Introducer is a device designed to stiffen the shaft of a Mini Compact Balloon Button (Mini-Button) making it easier to change.
It may be useful to use the AMT Introducer with the Mini-Button if the stoma tract is;
- Long
- Tight
- Not straight
The AMT Introducer should only be used with an AMT Mini Compact balloon button it is not designed for use with other types of gastrostomy device.
The AMT Introducer comes in two parts a clamp and a soft plastic stiffening stylet.
- Insert the rounded tip of the clamp into the new Mini-Button feeding port.
- Insert the stiffener through the clamp until it reaches to just before the end of the Mini-Button shaft
- Lock the stiffener in place by squeezing the AMT Introducer Clamp shut. Verify the stiffener is locked in after clamping.
- Insert the Mini-Button into the stoma as normal. It may be useful to hold the shaft of the Mini-Button close to the tip to initiate entry into the stoma.
- Once the Mini-Button is fully inserted, unclamp the AMT Introducer Clamp and remove the stylet.
IMPORTANT: To avoid damage to the Mini-Buttons internal valve, always remove the stylet before the AMT Introducer Clamp.
- Gently remove the AMT Introducer Clamp while holding the Mini-Buttons external bolster against the patient to prevent inadvertent feeding device removal.
- Inflate the retention balloon to the volume shown on the balloon inflation port
Use only the AMT Introducer to stiffen the Mini Button. No other object should be placed into the Mini-Button to aid insertion.
The AMT Introducer should only be used with an AMT Mini Compact Balloon Button it is not designed for use with other types of gastrostomy device.
Device Characteristics
What MRI safety information does the labeling contain? | Labeling does not contain MRI Safety Information |
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): | No |
Device labeled as "Not made with natural rubber latex": | Yes |
For Single-Use: | Yes |
Prescription Use (Rx): | Yes |
Over the Counter (OTC): | No |
Kit: | No |
Combination Product: | No |
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P): | No |