Duns Number:961627382
Device Description: The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero N 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, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block and lubrication jelly.
Catalog Number
-
Brand Name
EnsoETM
Version/Model Number
ECD06-A
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
JAY
Product Code Name
Support, Breathing Tube
Public Device Record Key
7f1d732c-f02f-4956-9f31-5c379b0465d1
Public Version Date
October 09, 2018
Public Version Number
1
DI Record Publish Date
September 08, 2018
Package DI Number
20857915006146
Quantity per Package
1
Contains DI Package
10857915006149
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper 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 |