Duns Number:961627382
Device Description: The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gay The Esophageal Cooling Device is a thermal regulating device, intended to connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and provide gastric decompression and suctioning.
Catalog Number
-
Brand Name
Esophageal Cooling Device
Version/Model Number
ECD01-A
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2017
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
bcdc0c1c-0e55-467f-863d-1d55967a47cc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
20857915006009
Quantity per Package
1
Contains DI Package
10857915006002
Package Discontinue Date
December 31, 2017
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 |