EnsoETM

Primary DI
20857915006160
Brand
EnsoETM
Company
Attune Medical
Model
ECD01-A
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. The EnsoETM is packaged with a universal bite block and lubrication jelly.
Published
2018-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PLAEsophageal Thermal Regulation And Gastric Suctioning Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PLAEsophageal Thermal Regulation And Gastric Suctioning DeviceCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857915006163PackageGS14In Commercial Distribution
20857915006160PackageGS11In Commercial Distribution
00857915006166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791500616310857915006163
2085791500616020857915006160
00857915006166008579150061668579150061660857915006166

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic bite block, basic, single-useA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 888-534-4873info@attune-medical.com
+1 408-470-7170CustomerServiceNA@haemonetics.com

Regulatory Flags#

DUNS number
961627382
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20857915006122EnsoETMECD05-A2018-09-08
20857915006146EnsoETMECD06-A2018-09-08
20857915006184EnsoETMECD02-A2018-05-17
20857915006207EnsoETMECD03-A2018-05-17
20857915006221EnsoETMECD04-A2018-05-17
20857915006009Esophageal Cooling DeviceECD01-A2016-09-24
20857915006016Esophageal Cooling DeviceECD02-A2016-09-24
20857915006047EnsoETMECD01-A2017-07-24
20857915006054EnsoETMECD02-A2017-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850041319001EsoCoolNuvaira, Inc.PLA2025-01-29
00850041319018EsoCoolNuvaira, Inc.PLA2025-01-29
00857915006128EnsoETMAdvanced Cooling Therapy, LLCPLA2018-09-08
00857915006142EnsoETMAdvanced Cooling Therapy, LLCPLA2018-09-08
00857915006166EnsoETMAdvanced Cooling Therapy, LLCPLA2018-05-17
00857915006180EnsoETMAdvanced Cooling Therapy, LLCPLA2018-05-17
00857915006203EnsoETMAdvanced Cooling Therapy, LLCPLA2018-05-17
00857915006227EnsoETMAdvanced Cooling Therapy, LLCPLA2018-05-17
00857915006043EnsoETMAdvanced Cooling Therapy, LLCPLA2017-07-24
00857915006050EnsoETMAdvanced Cooling Therapy, LLCPLA2017-07-24
20857915006047EnsoETMAttune MedicalPLA2017-07-24
20857915006054EnsoETMAttune MedicalPLA2017-07-24
00857915006005Esophageal Cooling DeviceAdvanced Cooling Therapy, LLCPLA2016-09-24
00857915006012Esophageal Cooling DeviceAdvanced Cooling Therapy, LLCPLA2016-09-24
20857915006009Esophageal Cooling DeviceAttune MedicalPLA2016-09-24
20857915006016Esophageal Cooling DeviceAttune MedicalPLA2016-09-24