ECD02-A: Haemonetics Attune ensoETM Esophageal Cooling Device

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Haemonetics Attune ensoETM Esophageal Cooling Device

The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.

Product Code: ECD02-A

• ensoETM Catheter
• Universal Bite Block
• Lubricating Jelly Packets, 5g (QTY 5)

Additional Details

• Company Name: Advanced Cooling Therapy, LLC
• FDA Product Code: PLA
• FDA Product Code Name: Esophageal Thermal Regulation And Gastric Suctioning Device
• FDA Product Code: KMJ
• FDA Product Code Name: Lubricant, Patient 
• FDA Product Code: JAY
• FDA Product Code Name: Support, Breathing Tube 
• FDA Product Code: PIO
• FDA Product Code Name: Enteral Specific Transition Connectors 
• GMDN Term Code: 34143
• GMDN Term Name: Endoscopic bite block, basic, single-use
• GMDN Term Definition: A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.
• GMDN Term Code: 62448
• GMDN Term Name: Core temperature regulation orogastric tube
• GMDN Term Definition: A multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) core temperature regulation, via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature). It is typically a coaxial tube which includes an orogastric lumen, intended to allow access to the stomach for feeding/decompression/medication administration, and a closed circulating-fluid circuit intended to be connected to an appropriate core temperature regulation system pump. This is a single-use device.
• GMDN Term Code: 64469
• GMDN Term Name: ENFit/non-ISO80369-standardized linear connector
• GMDN Term Definition: A small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.
• GMDN Term Code: 60796
• GMDN Term Name: General-body orifice lubricant
• GMDN Term Definition: A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.

Haemonetics is a global leader in advanced blood management solutions, providing innovative medical technologies like the Cell Saver Elite® autotransfusion system, TEG® hemostasis analyzer, and the ACP® 215 automated cell processor. Specializing in blood collection, processing, and transfusion management, Haemonetics products deliver improved clinical outcomes, enhanced patient safety, and greater operational efficiency in hospitals and surgical centers. Synergy Surgical offers Haemonetics solutions, empowering healthcare providers with trusted devices for optimal blood management and patient care.