EvoEndo Model LE Single-Use Gastroscope 1001

GUDID 00850031897014

The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasal diagnostic endoscopy in adult and pediatric patients. The EvoEndo Endoscope is ethylene oxide (EO) sterilized and is comprised of: - Handle - Umbilical Bundle that includes air, water, and suction lines, as well as the video connector - Endoscope shaft with HD Camera

Evoendo, Inc.

Flexible video gastroscope, single-use

• Primary Device ID: 00850031897014
• NIH Device Record Key: 49e8e2cf-6a08-4dc2-ae33-6c9653c0f5b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EvoEndo Model LE Single-Use Gastroscope
• Version Model Number: LE
• Catalog Number: 1001
• Company DUNS: 117077970
• Company Name: Evoendo, 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: 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

Device Dimensions

• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter
• Outer Diameter: 3.5 Millimeter
• Lumen/Inner Diameter: 2 Millimeter
• Length: 1.1 Meter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850031897014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213606

FDA Product Code

• FDS: Gastroscope And Accessories, Flexible/Rigid

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-03-07
• Device Publish Date: 2022-02-25

On-Brand Devices [EvoEndo Model LE Single-Use Gastroscope]

• 00850031897038: The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasa
• 00850031897014: The EvoEndo Endoscope is a sterile, single use gastroscope intended to perform oral or transnasa