Merlyn EndoTube 401030

GUDID 00182151000020

3.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and smooth Murphy tip

MERLYN ASSOCIATES, INC.

Basic endotracheal tube, single-use

• Primary Device ID: 00182151000020
• NIH Device Record Key: 945c6891-5cfa-47c3-ac26-3d07d8407955
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merlyn EndoTube
• Version Model Number: Oral/Nasal 401030
• Catalog Number: 401030
• Company DUNS: 606864184
• Company Name: MERLYN ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Lumen/Inner Diameter: 3 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 32 Degrees Fahrenheit and 120 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00182151000020 [Primary]
GS1	10182151000027 [Package]; Package: inner carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042683

FDA Product Code

• BTR: Tube, Tracheal (W/Wo Connector)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-06-01

On-Brand Devices [Merlyn EndoTube]

• 10182151000522: 6.0mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000515: 5.5mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000508: 5.0mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000492: 3.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000485: 6.0mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000478: 5.5mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000461: 5.0mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000454: 4.5mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000447: 4.5mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000430: 3.5mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000423: 3.0mm ID preformed nasal uncuffed endotracheal tube with Magill curve, radiopaque line and smoot
• 10182151000416: 7.0mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000409: 6.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000393: 6.0mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000386: 5.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000379: 5.0mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000362: 4.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000355: 4.0mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000348: 3.5mm ID preformed nasal cuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000331: 6.0mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000324: 5.5mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000317: 5.0mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000300: 4.5mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000294: 4.0mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000287: 3.5mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000270: 3.0mm ID preformed oral uncuffed endotracheal tube with Magill curve, radiopaque line and smooth
• 10182151000263: 8.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000256: 7.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000249: 7.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000232: 6.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000225: 6.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000218: 5.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000201: 5.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000195: 4.5mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000188: 4.0mm ID preformed oral cuffed endotracheal tube with Magill curve, radiopaque line and smooth M
• 10182151000171: 4.5mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000164: 4.0mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000157: 3.5mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000140: 3.0mm ID oral/nasal endotracheal tube uncuffed with, Magill curve, radiopaque line and smooth Mu
• 10182151000133: 8.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000126: 8.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000119: 7.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000102: 7.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000096: 6.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000089: 6.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000072: 5.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000065: 5.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000058: 4.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000041: 4.0mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm
• 10182151000034: 3.5mm ID oral/nasal endotracheal tube with inflatable cuff, Magill curve, radiopaque line and sm