Endure ETPOC656

GUDID B531ETPOC6562

Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.5 mm Inner Diameter

ENDURE INDUSTRIES

Basic endotracheal tube, single-use

• Primary Device ID: B531ETPOC6562
• NIH Device Record Key: d1c32dcb-7b50-4938-9a6d-d88cb30745a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endure
• Version Model Number: ETPOC6561017
• Catalog Number: ETPOC656
• Company DUNS: 066087031
• Company Name: ENDURE INDUSTRIES
• 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: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 6072994971
• Email: support@endureind.com
• Phone: 6072994971
• Email: support@endureind.com

Device Dimensions

• Lumen/Inner Diameter: 6.5 Millimeter
• Lumen/Inner Diameter: 6.5 Millimeter

Operating and Storage Conditions

• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 49 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B531ETPOC6560 [Primary]
HIBCC	B531ETPOC6561 [Package]; Contains: B531ETPOC6560; Package: Box [10 Units]; In Commercial Distribution
HIBCC	B531ETPOC6562 [Package]; Contains: B531ETPOC6561; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080105

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: 2018-02-21

On-Brand Devices [Endure]

• B531YSBVS20: Yankauer Suction Handle, with Bulbous Tip, Vented, Sterile
• B531YSBNS20: Yankauer Suction Handle, with Bulbous Tip, Non-Vented, Sterile
• B531STS162020: Suction Connection Tubing, 2 meters, 1/4 inch internal diameter, Sterile
• B531OMTX22: Oxygen Mask and Tubing, Size Extra Large, Non-Sterile
• OMTL22: Oxygen Mask and Tubing, Size Large, Non-Sterile
• B531OA922: Oropharyngeal Airway, Size 90 mm (Manufacture's Size "3"), Non-Sterile
• B531OA822: Oropharyngeal Airway, Size 80 mm, Non-Sterile
• B531OA722: Oropharyngeal Airway, Size 70, Non-Sterile
• B531OA622: Oropharyngeal Airway, Size 60, Non-Sterile
• B531OA522: Oropharyngeal Airway, Size 50, Non-Sterile
• B531OA422: Oropharyngeal Airway, Size 40, Non-Sterile
• B531OA1222: Oropharyngeal Airway, Size 120 mm, Non-Sterile
• B531OA1122: Oropharyngeal Airway, Size 110 mm, Non-Sterile
• B531OA1022: Oropharyngeal Airway, Size 100 mm, Non-Sterile
• B531NPS3420: Nasopharyngeal Airway, Size = 34 Fr, Internal Diameter 7.5 inches
• B531NPS3220: Nasopharyngeal Airway, Size = 32 Fr, Internal Diameter 7 inches
• B531NPS3020: Nasopharyngeal Airway, Size = 30 Fr, Internal Diameter 6.5 inches
• B531NPS2820: Nasopharyngeal Airway, Size = 28 Fr, Internal Diameter 6 inches
• B531NCX422: Nasal Oxygen Cannula, Size Extra Large, Length 4 Meters
• B531NCX222: Nasal Oxygen Cannula, Size Extra Large, Length 2 Meters
• B531NCS422: Nasal Oxygen Cannula, Size Small, Length 4 meters
• B531NCS222: Nasal Oxygen Cannula, Size Small, Length 2 Meters
• B531NCM422: Nasal Oxygen Cannula, Size Medium, Length 4 meters
• B531NCM222: Nasal Oxygen Cannula, Size Medium, Length 2 meters
• B531NCL422: Nasal Oxygen Cannula, Size Large, Length 4 Meters
• B531NCL222: Nasal Oxygen Cannula, Size Large, Length 2 meters
• B531ETRC7552: Endotracheal Tube, Reinforced, Cuffed, Size = 7.5 mm Inner Diameter.
• B531ETRC7052: Endotracheal Tube, Reinforced Type, Cuffed, Size = 7 mm Inner Diameter.
• B531ETPOU5062: Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 5.0 mm, Sterile
• B531ETPOU4562: Endotracheal Tube, Preformed, Oral, Uncuffed, Size 4.5 mm, Sterile
• B531ETPOU4062: Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 4.0 mm Internal Diameter, Sterile
• B531ETPOU3562: Endotracheal Tube, Preformed, Oral, Uncuffed, Sterile, Size 3.5 mm Internal Diameter
• B531ETPOU3062: Endotracheal Tube, Preformed, Oral Type, Uncuffed, Size 3.0 mm Internal Diameter, Sterile
• B531ETPOC8062: Preformed Endotracheal Tube, Oral, Cuffed, Size = 8.0 mm Inner Diameter
• B531ETPOC7562: Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.5 mm Inner Diameter, Sterile
• B531ETPOC7062: Preformed Endotracheal Tube, Oral, Cuffed, Size = 7.0 mm Inner Diameter
• B531ETPOC6562: Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.5 mm Inner Diameter
• B531ETPOC6062: Preformed Endotracheal Tube, Oral, Cuffed, Size = 6.0 mm Inner Diameter
• B531ETPOC5562: Preformed Endotracheal Tube, Oral, Cuffed, Size = 5.5 mm Inner Diameter
• B531ETPOC5062: Preformed Endotracheal Tube, Oral, Cuffed, Size = 5.0 mm Inner Diameter
• B531ETPOC4560: Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.5 mm Inner Diameter
• B531ETPOC4062: Preformed Endotracheal Tube, Oral, Cuffed, Size = 4.0 mm Inner Diameter
• B531ETPNC7562: Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.5 mm internal diameter
• B531ETPNC7062: Endotracheal Tube, Preformed, Nasal, Cuffed, Size 7.0 mm Internal Diameter, Sterile
• B531ETPNC6562: Endotracheal Tube, Preformed, Nasal, Cuffed, Size 6.5 mm Internal Diameter, Sterile
• B531ETPNC6062: Endotracheal Tube, Preformed, Nasal, Cuffed, Size 6.0 mm Internal Diameter, Sterile
• B531ETNU7552: Endotracheal Tube, Standard Type, Uncuffed, Size = 7.5 mm Inner Diameter.
• B531ETNU7052: Endotracheal Tube, Standard Type, Uncuffed, Size = 7.0 mm Inner Diameter.
• B531ETNU5552: Endotracheal Tube, Standard Type, Uncuffed, Size = 5.5 mm Inner Diameter.
• B531ETNU5052: Endotracheal Tube, Standard Type, Uncuffed, Size = 5.0 mm Inner Diameter.