DEVICE: EnsoETM (00857915006227)

Device Identifier (DI) Information

EnsoETM
ECD04-A
In Commercial Distribution

Attune Medical
00857915006227
GS1

1
961627382 *Terms of Use
The EnsoETM 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, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
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?
34143 Endoscopic bite block, basic, single-use
A device intended to be inserted into a patient''s mouth to maintain oral patency during an endoscopic procedure primarily to protect the endoscope, introduced via the mouth, from the patient''s natural tendency to bite down on the instrument, thereby causing damage. The device is also intended to protect the tongue and teeth of the patient during endoscopy. It is a basic device and does not include additional functions/features such as lumen to support introduction of an oxygen (O2) line. This is a single-use device.
Active false
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
60796 General-body orifice lubricant
A substance intended to facilitate entry of a diagnostic or therapeutic device into a body orifice by reducing friction between the device and the body; it is not dedicated to a particular part of the anatomy. After application, this device cannot be reused.
Active false
64469 ENFit/non-ISO80369-standardized linear connector
A small, non-powered, noninvasive, tubular two-way/linear connector with an ENFit connection (designed according to ISO 80369-3 for enteral applications) at one end and a connection which is not designed according to ISO 80369 at the other end (typically barbed, conical, ENLock, threaded or non-Luer-slip), intended to connect an enteral device (e.g., enteral syringe, feeding tube, administration set) with an ENFit connection typically with tubing or syringe; it does not connect a vial/bottle (i.e., not a vial/bottle adaptor). It does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp nor tubing. This is a single-use device.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KMJ Lubricant, Patient
JAY Support, Breathing Tube
PIO Enteral Specific Transition Connectors
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
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

9221ee13-b0fc-44af-88ac-05c19b9dcff5
December 18, 2023
3
May 17, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
20857915006221 1 10857915006224 In Commercial Distribution Shipping Box
10857915006224 4 00857915006227 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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
Yes
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1 888-534-4873
info@attune-medical.com
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