FDA.reportPublic FDA data

EnsoETM

Primary DI
00857915006142
Brand
EnsoETM
Company
Advanced Cooling Therapy, LLC
Model
ECD06-A
Device description
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.
Published
2018-09-08
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
JAYSupport, Breathing Tube
KMJLubricant, Patient
PLAEsophageal Thermal Regulation And Gastric Suctioning Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAYSupport, Breathing TubeAnesthesiology1
KMJLubricant, PatientGeneral Hospital1
PLAEsophageal Thermal Regulation And Gastric Suctioning DeviceCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857915006149PackageGS14Not in Commercial Distribution
20857915006146PackageGS11Not in Commercial Distribution
00857915006142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791500614910857915006149
2085791500614620857915006146
00857915006142008579150061428579150061420857915006142

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
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
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
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