EnsoETM

Basic Information

• Brand Name: EnsoETM
• Primary DI: 00857915006043
• Version / Model: ECD01-A
• Company Name: Attune Medical
• Labeler DUNS: 961627382
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-07-24
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: c71561ff-732d-4213-94db-32589c5cfd7a
• Distribution End Date: 2018-05-30

Device Description

The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature, and provide gastric decompression and suctioning.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Cardiovascular	870.5910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20857915006047	GS1	Shipping Box	1	Not in Commercial Distribution	2018-05-30
Package	10857915006040	GS1	Shelf Box	4	Not in Commercial Distribution	2018-05-30
Primary	00857915006043	GS1

Customer Contacts

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