Applied Medical Technology 4-2012-ISOSAF - ENFit Single Port Adapter ISOSAF - Enteral feeding accessories 12Fr Replacement End Single Purple Strap Cap and ENFit Connector, 10/BX
4-2014-ISOSAF -14Fr Replacement End Single Purple Strap Cap and ENFit Connector, 10/BX
A sterile connecting device shaped in the form of a "Y" intended for connection to the proximal end of a gastrostomy tube to enable administration of nutrient liquids and/or medication through the gastrostomy tube. It has two resealable ports intended for flushing the line and/or administering medications without the need for tube disconnection or interruption of an enteral feed.
For Capsule Dome G-Tube and Capsule Monarch G-Tube
AMT has three main Traditional Length G-Tubes, the Capsule Dome, the Capsule Monarch, and the Balloon G-Tube. These devices are placed through the abdominal wall and have an adjustable external bolster. This adjustable external bolster minimizes surface contact with skin, allowing tissue to breathe and can be adjusted up to 10cm in length. The Capsule Dome and the Capsule Monarch have replacement y-ports based on the French size of the device!
What is ENFit?
The International Organization for Standardization (ISO) has created a new standard design for enteral connectors, termed the "ENFit Connector."
These new ENFit Connectors are intended to improve patient safety and to decrease the risk of medical device misconnections. This new connector has been designed to be incompatible with Luer adapters, which are commonly used in IV applications. The ENFit connector will look & secure very similar to a Luer threaded lock system, although the design is larger and thus, incompatible with Luers.
Why ENFit?
ENFit is a patient safety initiative, designed to ensure that feeding tube connectors are incompatible with the connectors for unrelated delivery systems such as trach tubes, IV lines, and catheters. Misconnections involving such medical devices may be relatively rare compared with the number of patients needing tubes or IVs, but such misconnections can have deadly consequences when they do occur.
ENFit is a global initiative that affects end users, manufacturers, and suppliers. The ENFitConnectors were developed as part of the Stay Connected initiative under the supervision of clinicians, manufacturers, and regulators.
Volumetric Information
| Height | 270 mm |
| Width | 240 mm |
| Depth | 55 mm |
| Weight | 1 kg |
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 |
Applied Medical Technology #4-2014-ISOSAF, ENFit Single Port Adapter ISOSAF - Enteral feeding accessories 14Fr Replacement End Single Purple Strap Cap and ENFit Connector, 10/BX
