Screeni 30030001
GUDID 03664977030032
Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display live imaging data captured by sterile disposable endoscopes (Broncoflex Agile or Vortex).
AXESS VISION TECHNOLOGY
Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use Flexible video bronchoscope, single-use| Primary Device ID | 03664977030032 |
| NIH Device Record Key | 229c29d9-33fa-46b4-a272-3d21c8199552 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Screeni |
| Version Model Number | 30030001 |
| Catalog Number | 30030001 |
| Company DUNS | 285985615 |
| Company Name | AXESS VISION TECHNOLOGY |
| 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 | 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 |
Device Dimensions
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
| Length | 300 Millimeter |
| Height | 200 Millimeter |
| Depth | 110 Millimeter |
| Weight | 1.8 Kilogram |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 80 KiloPascal and 109 KiloPascal |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -10 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03664977030032 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K202180
FDA Product Code
| EOQ | Bronchoscope (Flexible Or 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 | 2020-12-18 |
| Device Publish Date | 2020-12-10 |
Devices Manufactured by AXESS VISION TECHNOLOGY
| 03664977000011 - Easy BAL Clip™ | 2023-08-07 The Easy BAL Clip™ is a non-sterile, single-use device designed as an add-on to the Broncoflex™ during a Broncho Alveolar La |
| 03664977010034 - Broncoflex Vortex | 2020-12-18 Broncoflex Vortex is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reu |
| 03664977020033 - Broncoflex Agile | 2020-12-18 Broncoflex Agile is a single-use video-bronchoscope which is part of a system made up of the endoscope (Broncoflex) and its reus |
| 03664977030032 - Screeni | 2020-12-18Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display live imaging data captured by sterile disposable endoscopes (Broncoflex Agile or Vortex). |
| 03664977030032 - Screeni | 2020-12-18 Screeni is a non-sterile reusable medical device. It is a video processor with integrated touch interface designed to display li |
Trademark Results [Screeni]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SCREENI 79340638 not registered Live/Pending |
AXESS VISION TECHNOLOGY 2022-04-08 |
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