DEVICE: Merlyn EndoTube (00182151000082)

Device Identifier (DI) Information

Merlyn EndoTube
Oral/Nasal 401060
In Commercial Distribution
401060
MERLYN ASSOCIATES, INC.
00182151000082
GS1

1
606864184 *Terms of Use
6.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip
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Device Characteristics

Labeling does not contain MRI Safety Information
Yes
No
Yes
Yes
No
No
No
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
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.
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FDA Product Code

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Product Code Product Code Name
BTR Tube, Tracheal (W/Wo Connector)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042683 000
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Sterilization

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

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Storage and Handling
Handling Environment Temperature: between 32 and 120 Degrees Fahrenheit
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Clinically Relevant Size

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Size Type Text
Lumen/Inner Diameter: 6.0 Millimeter
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Device Record Status

a9db817a-64cb-4e5e-ac20-e6dc4ed3717f
July 06, 2018
3
June 01, 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
10182151000089 10 00182151000082 In Commercial Distribution inner carton
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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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No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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