EndoFlex 121080

GUDID 00182151000556

8.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque line and smooth Murphy tip

MERLYN ASSOCIATES, INC.

Basic endotracheal tube, single-use

• Primary Device ID: 00182151000556
• NIH Device Record Key: f0de7587-b282-4327-aa7a-61deb06182ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoFlex
• Version Model Number: Oral/Nasal 121080
• Catalog Number: 121080
• 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: 8 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00182151000556 [Primary]
GS1	10182151000553 [Package]; Package: inner carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031794

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 [EndoFlex]

• 10182151000584: 8.0mm ID oral/nasal endotracheal tube with inflatable tapered cuff, Magill curve, radiopaque lin
• 10182151000577: 7.5mm ID oral/nasal endotracheal tube with inflatable tapered cuff, Magill curve, radiopaque lin
• 10182151000560: 7.0mm ID oral/nasal endotracheal tube with inflatable tapered cuff, Magill curve, radiopaque lin
• 00182151000556: 8.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque lin
• 10182151000546: 7.5 mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque li
• 10182151000539: 7.0mm ID oral/nasal endotracheal tube with inflatable rounded cuff, Magill curve, radiopaque lin