EnsoETM

Basic Information

• Brand Name: EnsoETM
• Primary DI: 00857915006128
• Version / Model: ECD05-A
• Company Name: Advanced Cooling Therapy, LLC
• Labeler DUNS: 961627382
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-08
• Public Version: 6
• Public Version Date: 2025-07-08
• Public Version Status: Update
• Public Device Record Key: 90a3e67a-6a27-4607-b3f3-b0b7ae240010
• Distribution End Date: 2022-10-04

Device Description

The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PIO	Enteral Specific Transition Connectors	Gastroenterology, Urology	876.5980	2
JAY	Support, Breathing Tube	Anesthesiology	868.5280	1
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Cardiovascular	870.5910	2
KMJ	Lubricant, Patient	General Hospital	880.6375	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34143	Endoscopic bite block, basic, single-use	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.	No	Active
60796	General-body orifice lubricant	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.	No	Active
62448	Core temperature regulation orogastric tube	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.	No	Active
64469	ENFit/non-ISO80369-standardized linear connector	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20857915006122	GS1	Shipping Box	1	Not in Commercial Distribution	2022-10-04
Package	10857915006125	GS1	Shelf Box	4	Not in Commercial Distribution	2022-10-04
Primary	00857915006128	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]