GENOSYL® 601588
GUDID 00850000962026
GENOSYL Delivery System
Vero Biotech Inc.
Nitric oxide delivery unit, system-based| 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
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 |
| 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 |
| 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 |
| 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 |
| 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 |
Trademark Results [GENOSYL]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENOSYL 87772550 not registered Live/Pending |
VERO BIOTECH, LLC 2018-01-26 |
 GENOSYL 85981080 4496333 Live/Registered |
GeNO LLC 2011-12-02 |
 GENOSYL 85485604 4700107 Live/Registered |
VERO BIOTECH, LLC 2011-12-02 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.