FDA.reportPublic FDA data

EnsoETM

Primary DI
20857915006122
Brand
EnsoETM
Company
Attune Medical
Model
ECD05-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, 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.
Published
2018-09-08
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
PIOEnteral Specific Transition Connectors

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PIOEnteral Specific Transition ConnectorsGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857915006125PackageGS14In Commercial Distribution
20857915006122PackageGS11In Commercial Distribution
00857915006128PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085791500612510857915006125
2085791500612220857915006122
00857915006128008579150061288579150061280857915006128

GMDN Terms#

Term, Definition table
TermDefinition
Thermal-regulation orogastric tubeA non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) thermal regulation of the whole body 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 thermal therapy system pump. 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
20857915006146EnsoETMECD06-A2018-09-08
20857915006160EnsoETMECD01-A2018-05-17
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
00842071133245ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133252ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133269ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133276ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133283ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133290ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133306ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133313ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133320ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133337ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133344ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
00842071133351ENFit Transition AdapterAPPLIED MEDICAL TECHNOLOGY, INC.PIO2025-05-28
10192253009644KangarooCardinal Health 200, LLCPIO2024-03-26
20192253009641KangarooCardinal Health 200, LLCPIO2024-03-26
10888277314719MedlineMEDLINE INDUSTRIES, INC.PIO2022-12-02
40888277314710MedlineMEDLINE INDUSTRIES, INC.PIO2022-12-02
10884389196915MedlineMEDLINE INDUSTRIES, INC.PIO2020-12-17
40884389196916MedlineMEDLINE INDUSTRIES, INC.PIO2020-12-17
08056093721096Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2020-03-11
08056093720549Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2020-03-11
08056093720716Enteral distal end ENFit Transition ConnectorCEDIC SRLPIO2019-08-20
08056093720723AVANOSCEDIC SRLPIO2019-08-20
08056093721072ENConnect 40 mm Screw Cap to ENPlus Adapter CEDIC SRLPIO2019-06-06
08056093720563ENConnect Male Distal End Stepped AdapterCEDIC SRLPIO2019-01-29
08056093720594ENConnect ENFit Funnel Adapter CEDIC SRLPIO2019-01-29
08056093720686ENConnect ENFit to Oral/Luer syringe adapterCEDIC SRLPIO2019-01-29
08056093720709ENConnect ENFit to Oral/Luer syringe adapterCEDIC SRLPIO2019-01-29
00857915006128EnsoETMAdvanced Cooling Therapy, LLCPIO2018-09-08
08056093720297Enteral Funnel ENFIt Transition Connector with capCEDIC SRLPIO2018-07-03
00857915006203EnsoETMAdvanced Cooling Therapy, LLCPIO2018-05-17