DEVICE: Esophageal Cooling Device (00857915006012)

Device Identifier (DI) Information

Esophageal Cooling Device
ECD02-A
Not in Commercial Distribution

Attune Medical
00857915006012
GS1
December 31, 2017
1
961627382 *Terms of Use
The Esophageal Cooling Device 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.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
No
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No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Thermal-regulation orogastric tube A non-sterile, multi-lumen, multi-purpose tube intended for oral introduction into the gastrointestinal (GI) tract for both: 1) enteral feeding/gastric decompression; and 2) thermal regulation of the whole body 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 thermal therapy system pump. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
PLA Esophageal Thermal Regulation And Gastric Suctioning Device
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

5f49f53d-edee-4afb-9a9c-f24ff8efe310
March 29, 2018
2
September 24, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20857915006016 1 10857915006019 2017-12-31 Not in Commercial Distribution Shipping Box
10857915006019 4 00857915006012 2017-12-31 Not in Commercial Distribution Shelf Box
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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Yes
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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888-534-4873
info@advancedcoolingtherapy.com
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