FDA.reportPublic FDA data

EnsoETM

Primary DI
00857915006166
Brand
EnsoETM
Company
Advanced Cooling Therapy, LLC
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, 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.
Published
2018-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JAYSupport, Breathing Tube
KMJLubricant, Patient
PLAEsophageal Thermal Regulation And Gastric Suctioning Device
QXVTemperature Regulation Device For Esophageal Protection During Cardiac Ablation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1
KMJLubricant, PatientGeneral Hospital1
PLAEsophageal Thermal Regulation And Gastric Suctioning DeviceCardiovascular2
QXVTemperature Regulation Device For Esophageal Protection During Cardiac AblationCardiovascular2

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.

Contacts#

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

Regulatory Flags#

DUNS number
961627382
Device count
1
DM exempt
true
Kit
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
00857915006005Esophageal Cooling DeviceECD01-A2016-09-24
00857915006012Esophageal Cooling DeviceECD02-A2016-09-24
00857915006043EnsoETMECD01-A2017-07-24
00857915006050EnsoETMECD02-A2017-07-24
00857915006128EnsoETMECD05-A2018-09-08
00857915006142EnsoETMECD06-A2018-09-08
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
15019517382518ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-06-01
08887500730017SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730024SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
08887500730031SuperSlydeICM PHARMA PTE. LTD.KMJ2026-04-29
15019517382488ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382495ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
15019517382501ICU Medical, Inc.ICU MEDICAL, INC.JAY2026-04-06
10889483228579Capette™SUNMED, LLCJAY2025-12-31
10889483225462Septal-H™SUNMED, LLCJAY2025-12-16
00627987071429NixitMAYER LABORATORIES, INC.KMJ2025-09-16
30080196074192MEDLINEMEDLINE INDUSTRIES, INC.KMJ2025-04-25
10850014574625PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
10850014574632PreVent Endo HolderPEPPER MEDICAL INC.JAY2025-03-26
00860013561406MPVMovair, Inc.JAY2025-03-12
00860013561413MPVMovair, Inc.JAY2025-03-12
00850025860482Endoscopy Kit - Basic + GownsMicro-tech UsaKMJ2025-03-04
00850025860062Endoscopy Kit - Basic+Micro-tech UsaKMJ2025-03-03
00850025860215Endoscopy Kit - Compliance+Micro-tech UsaKMJ2025-03-03
00850025860277Endoscopy Kit - ComplianceMicro-tech UsaKMJ2025-03-03
00850041319001EsoCoolNuvaira, Inc.PLA2025-01-29
00850041319001EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.KMJ2025-01-29
00850041319018EsoCoolNuvaira, Inc.PLA2025-01-29
00850058254623EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254630EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254647EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
00850058254654EZ LubricatingHR PHARMACEUTICALS INC.KMJ2025-01-16
B960RED202RED Prep-KitNeuraxis, Inc.KMJ2025-01-09
14026704921697ARROWTELEFLEX INCORPORATEDKMJ2024-04-08
40080196150091MedlineMEDLINE INDUSTRIES, INC.JAY2024-03-27