DEVICE: Merlyn EndoTube (00182151000525)
Device Identifier (DI) Information
Merlyn EndoTube
Oral/Nasal 411060
In Commercial Distribution
411060
MERLYN ASSOCIATES, INC.
Oral/Nasal 411060
In Commercial Distribution
411060
MERLYN ASSOCIATES, INC.
6.0mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Murphy tip
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Basic endotracheal tube, single-use | A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
BTR | Tube, Tracheal (W/Wo Connector) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K042683 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 32 and 120 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Lumen/Inner Diameter: 6.0 Millimeter |
Device Record Status
87746309-2220-49a0-80ad-f5268f171789
July 06, 2018
3
June 01, 2016
July 06, 2018
3
June 01, 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 |
---|---|---|---|---|---|
10182151000522 | 10 | 00182151000525 | In Commercial Distribution | inner carton |
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
[?]
No Customer Contact currently defined