Duns Number:961627382
Device Description: The EnsoETM is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III 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, and provide gastric decompression and suctioning.
Catalog Number
-
Brand Name
EnsoETM
Version/Model Number
ECD01-A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 30, 2018
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PLA
Product Code Name
Esophageal Thermal Regulation And Gastric Suctioning Device
Public Device Record Key
c71561ff-732d-4213-94db-32589c5cfd7a
Public Version Date
January 27, 2021
Public Version Number
3
DI Record Publish Date
July 24, 2017
Package DI Number
20857915006047
Quantity per Package
1
Contains DI Package
10857915006040
Package Discontinue Date
May 30, 2018
Package Status
Not in Commercial Distribution
Package Type
Shipping Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |