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EnsoETM

FDA UDI

Class II (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, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management 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. FDA UDI
Model / Reference
ECD01-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, connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management 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. FDA UDI

Identifiers

Primary DI / UDI-DI
00857915006166 FDA UDI
FDA Product Code
PLA FDA UDI
KMJ FDA UDI
JAY FDA UDI
QXV FDA UDI
GMDN Term
Endoscopic bite block, basic, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5910 FDA UDI
880.6375 FDA UDI
868.5280 FDA UDI
870.5720 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
MRI Safety
MR Safe FDA UDI

Category: General-body orifice lubricantEndoscopic bite block, basic, single-useCore temperature regulation orogastric tube

EnsoETM by Advanced Cooling Therapy, LLC — Class II — 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 6cde7477-2b1e-44b3-9a74-fff06a704de2 34 fields · synced May 31, 2026