DEVICE: Esophageal Cooling Device (00857915006005)
Device Identifier (DI) Information
Esophageal Cooling Device
ECD01-A
Not in Commercial Distribution
Attune Medical
ECD01-A
Not in Commercial Distribution
Attune Medical
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
62448 | Core temperature regulation orogastric tube |
A multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) core temperature regulation, via thermal transfer across the oesophagus (to lower and alternatively elevate core body temperature). It is typically a coaxial tube which includes an orogastric lumen, intended to allow access to the stomach for feeding/decompression/medication administration, and a closed circulating-fluid circuit intended to be connected to an appropriate core temperature regulation system pump. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
PLA | Esophageal Thermal Regulation And Gastric Suctioning Device |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
bcdc0c1c-0e55-467f-863d-1d55967a47cc
December 18, 2023
3
September 24, 2016
December 18, 2023
3
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
20857915006009 | 1 | 10857915006002 | 2017-12-31 | Not in Commercial Distribution | Shipping Box |
10857915006002 | 4 | 00857915006005 | 2017-12-31 | Not in Commercial Distribution | Shelf Box |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
888-534-4873
info@advancedcoolingtherapy.com
info@advancedcoolingtherapy.com