Esophageal Cooling Device

Primary DI
00857915006005
Brand
Esophageal Cooling Device
Company
Advanced Cooling Therapy, LLC
Model
ECD01-A
Device description
The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and provide gastric decompression and suctioning.
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
10857915006002PackageGS14Not in Commercial Distribution
20857915006009PackageGS11Not in Commercial Distribution
00857915006005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791500600210857915006002
2085791500600920857915006009
00857915006005008579150060058579150060050857915006005

GMDN Terms#

Term, Definition table
TermDefinition
Core temperature regulation orogastric tubeA 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.

Contacts#

Phone, Email table
PhoneEmail
+1 408-470-7170CustomerServiceNA@haemonetics.com

Regulatory Flags#

DUNS number
961627382
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857915006012Esophageal Cooling DeviceECD02-A2016-09-24
00857915006043EnsoETMECD01-A2017-07-24
00857915006050EnsoETMECD02-A2017-07-24
00857915006128EnsoETMECD05-A2018-09-08
00857915006142EnsoETMECD06-A2018-09-08
00857915006166EnsoETMECD01-A2018-05-17
00857915006180EnsoETMECD02-A2018-05-17
00857915006203EnsoETMECD03-A2018-05-17
00857915006227EnsoETMECD04-A2018-05-17

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
20857915006160EnsoETMAttune MedicalPLA2018-05-17
00857915006043EnsoETMAdvanced Cooling Therapy, LLCPLA2017-07-24
00857915006050EnsoETMAdvanced Cooling Therapy, LLCPLA2017-07-24
20857915006047EnsoETMAttune MedicalPLA2017-07-24
20857915006054EnsoETMAttune MedicalPLA2017-07-24
00857915006012Esophageal Cooling DeviceAdvanced Cooling Therapy, LLCPLA2016-09-24
20857915006009Esophageal Cooling DeviceAttune MedicalPLA2016-09-24
20857915006016Esophageal Cooling DeviceAttune MedicalPLA2016-09-24