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EnsoETM

FDA UDI

Class I (US FDA UDI)

by Advanced Cooling Therapy, LLC

Identity

Trade Name
EnsoETM FDA UDI
Generic Name
Endoscopic bite block, basic, single-use FDA UDI
Device Name
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, allow enteral administration of fluids, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly. FDA UDI
Model / Reference
ECD03-A FDA UDI
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, allow enteral administration of fluids, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly. FDA UDI

Identifiers

Primary DI / UDI-DI
00857915006203 FDA UDI
FDA Product Code
KMJ FDA UDI
JAY FDA UDI
PIO FDA UDI
PLA FDA UDI
GMDN Term
Endoscopic bite block, basic, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
880.6375 FDA UDI
868.5280 FDA UDI
876.5980 FDA UDI
870.5910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: General-body orifice lubricantEndoscopic bite block, basic, single-useENFit/non-ISO80369-standardized linear connectorCore temperature regulation orogastric tube

EnsoETM by Advanced Cooling Therapy, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Core temperature regulation orogastric tube.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Advanced Cooling Therapy, LLC

Sources (1)

  • FDA UDI a4c0e16c-1997-40a9-a61c-f67dd4709a02 34 fields · synced May 29, 2026