aBox Duodeno 485001000US

GUDID 05707480145362

aBox Duodeno

Ambu A/S

Endoscopic video image processing unit

• Primary Device ID: 05707480145362
• NIH Device Record Key: 9c2a4cfd-6c3d-4ff2-bd84-09380d7e8e84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: aBox Duodeno
• Version Model Number: 485001000US
• Catalog Number: 485001000US
• Company DUNS: 305682023
• Company Name: Ambu A/S
• 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com
• Phone: +14107686464
• Email: Purchase_orders@ambuUSA.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Handling Environment Atmospheric Pressure: Between 80 KiloPascal and 109 KiloPascal
• Storage Environment Temperature: Between 10 Degrees Celsius and 25 Degrees Celsius
• Handling Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05707480145362 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201098

FDA Product Code

• FDT: Duodenoscope and accessories, flexible/rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-18
• Device Publish Date: 2020-08-10

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