GENOSYL® 601588

GUDID 00850000962002

GENOSYL Delivery System

VERO BIOTECH LLC

Nitric oxide delivery unit, system-based

• Primary Device ID: 00850000962002
• 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 LLC
• 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: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@vero-biotech.com
• Phone: +1(908)399-3980
• Email: Al.Schweikert@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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850000962002 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-22
• Device Publish Date: 2020-05-14

On-Brand Devices [GENOSYL®]

• 00850000962057: GENOSYL DS Manual Ventilation Bag NO Adapter
• 00850000962040: GENOSYL DS Mixer
• 00850000962033: GENOSYL DS Gas Lines
• 00850000962002: GENOSYL Delivery System
• 00850000962088: 25 mm, 0.22µm Disc Filter
• 00850000962156: GENOSYL DS 22M x 22F Elbox Adapter
• 00850000962149: GENOSYL DS HFOV Gas Sampling Port
• 00850000962132: GENOSYL DS Vapotherm Acessory Kit
• 00850000962125: Gas Inlet Adapter
• 00850000962118: GENOSYL DS Vapotherm Accessory Kit
• 00850000962095: GENOSYL DS Bunnell Adapter
• 00850000962071: GENOSYL DS Vapotherm Accessory Kit
• 00850000962187: GENOSYL DS Bunnell Tee Adapters