Identity
- Trade Name
- EnsoETM FDA UDI
- Generic Name
- Core temperature regulation orogastric tube FDA UDI
- Device Name
- The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, and provide gastric decompression and suctioning. FDA UDI
- Model / Reference
- ECD02-A FDA UDI
- Description
- The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature, and provide gastric decompression and suctioning. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00857915006050 FDA UDI
- FDA Product Code
- PLA FDA UDI
- GMDN Term
- Core temperature regulation orogastric tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5910 FDA UDI
- Commercial Distribution
- Not 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
No
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
EnsoETM by Advanced Cooling Therapy, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Cooling Therapy, LLC
Sources (1)
- FDA UDI ecb6f8ec-6af5-4836-be0b-28241275c068 35 fields · synced May 30, 2026