GENOSYL® 601588

GUDID 00850000962026

GENOSYL Delivery System

Vero Biotech Inc.

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• Primary Device ID: 00850000962026
• NIH Device Record Key: 450e603c-f085-4ddb-8c2e-c6a586b03fce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GENOSYL®
• Version Model Number: 601588
• Catalog Number: 601588
• Company DUNS: 872672477
• Company Name: Vero Biotech Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: true
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com
• Phone: 678-661-5721
• Email: robyn.mcclure@vero-biotech.com

Device Dimensions

• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter
• Width: 40.6 Centimeter

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 57 KiloPascal and 110 KiloPascal
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *power supply should be connected once every 3 months
• Storage Environment Humidity: Between 0.15 Percent (%) Relative Humidity and 0.95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000962026 [Primary]

FDA Product Code

• MRN: APPARATUS, NITRIC OXIDE DELIVERY

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-07-25
• Device Publish Date: 2020-05-14

On-Brand Devices [GENOSYL®]

• 00850000962170: GENOSYL® DS Console
• 00850000962200: Adaptive Sensor
• 00850000962194: Adaptive Sensor Cable
• 00850000962026: GENOSYL Delivery System
• 00850000962316: Sample Gas Line Humidifier
• 00850000962231: Gas Line Set
• 00850000962101: Transport Mount Assembly
• 00850000962064: Sample Line Extension
• 00850000962019: Gas Line Set with Integrated Humidification Reservoir
• 00850000962323: NO Gas Injection Adapter 22M/15F X 22F
• 00850000962309: Straight Tee, 3/8 Barbed
• 00850000962293: 22F X 15M Adapter
• 00850000962286: 15M X 4.5 Adapter
• 00850000962279: 22M/15F X 15M Gas Sample Tee
• 00850000962262: 22M/15F X 22M/15F Adapter