DEVICE: TRACOE® care (04035324012251)
Device Identifier (DI) Information
TRACOE® care
REF 940-D
In Commercial Distribution
Tracoe medical GmbH
REF 940-D
In Commercial Distribution
Tracoe medical GmbH
TRACOE cleaning brushes for flexible tracheostomy tubes
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
No | |
Yes | |
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? |
---|---|---|---|---|
34883 | Airway device cleaning utensil, noninvasive, reusable |
A hand-held device intended to be used to clean an ex situ non-endoscopic airway device [e.g., endotracheal (ET) tube, tracheoesophageal speech valve, laryngeal airway], once it has been removed from the patient, to remove organic matter (e.g., phlegm). It is in the form of a flexible or rigid handle with distal soft or stiff bristles, fibres or spines, or a swab; it may be used in the home or healthcare facility. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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EPE | BRUSH, CLEANING, TRACHEAL TUBE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: no special storage conditions |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: bristle diameter: 13 mm total length: 36.0 mm |
Device Record Status
cba036bb-8736-4546-a3fc-dbcbacd1ecbd
March 29, 2018
2
March 15, 2016
March 29, 2018
2
March 15, 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 |
---|---|---|---|---|---|
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