DEVICE: TRACOE® modular (04035324016945)
Device Identifier (DI) Information
TRACOE® modular
REF 641
In Commercial Distribution
Tracoe medical GmbH
REF 641
In Commercial Distribution
Tracoe medical GmbH
TRACOE humid assist III, 50 units
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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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? |
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35530 | Heat/moisture exchanger, single-use |
A one-piece, canister-like device that connects in-line with a patient's artificial airway [e.g., an endotracheal (ET) tube], to capture the patient's exhaled heat and moisture so that they can be used to heat and humidify therapeutic gases inspired by the patient; it does not include a microbial filter. Commonly known as a heat & moisture exchanger (HME) or an "artificial nose", it is used when the patient is subjected to extended periods of breathing dry gases such as during anaesthesia or intensive care ventilation. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BYD | CONDENSER, HEAT AND MOISTURE (ARTIFICIAL NOSE) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Products must be stored in cool and dry location. Temporary storage for less or equal to 30 days at less or equal to +50 °C is possible. Protect product from sunlight and extreme cold. |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: Fits on 15 mm connector |
Device Record Status
ef275374-feb4-4e9d-ae98-ce78a927a4e6
March 29, 2018
2
October 18, 2015
March 29, 2018
2
October 18, 2015
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
+49613691690
info@tracoe.com
info@tracoe.com