FDA.reportPublic FDA data

Advanced Cooling Therapy, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30104124923010412492Advanced Cooling Therapy, LLC1Y2026-01-01125 Summer St Boston MA US 02110

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857915006005Esophageal Cooling Device - 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.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006012Esophageal Cooling Device - The Esophageal Cooling Device 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.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006043EnsoETM - 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.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006050EnsoETM - 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.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006128EnsoETM - 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.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006142EnsoETM - 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, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006166EnsoETM - 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, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision TemperatureManagement System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.+1 408-470-7170CustomerServiceNA@haemonetics.com
00857915006180EnsoETM - 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, connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.+1 408-470-7170CustomerServiceNA@haemonetics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1597801686709289K180742EnsoETMPLA2018-05-17
1597801821884803K180244EnsoETMPLA2018-02-28
1597801361012441K172493EnsoETMPLA2017-10-17
1597801710960611DEN230021ensoETMQXV2023-09-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PLA32018-05-17
QXV12023-09-13

PMN#

EnsoETM

2018-05-17

Advanced Cooling Therapy, Inc. D/b/a Attune Medical

EnsoETM

2018-02-28

Advanced Cooling Therapy, Inc. D/b/a Attune Medical

GUDID#

EnsoETM - 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, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision TemperatureManagement System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.

Advanced Cooling Therapy, LLC

2018-05-17

EnsoETM - 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, connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.

Advanced Cooling Therapy, LLC

2018-05-17