EnsoETM

Basic Information

• Brand Name: EnsoETM
• Primary DI: 00857915006050
• Version / Model: ECD02-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: ecb6f8ec-6af5-4836-be0b-28241275c068
• Distribution End Date: 2018-10-12

Device Description

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, 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	20857915006054	GS1	Shipping Box	1	Not in Commercial Distribution	2018-10-12
Package	10857915006057	GS1	Shelf Box	4	Not in Commercial Distribution	2018-10-12
Primary	00857915006050	GS1

Customer Contacts

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