PlasmaTYPHOON
GUDID 03701354400115
PlasmaTYPHOON - unit for fast drying of endoscope channels and active storage of endoscopes Voltage: 100-120 VAC Frequency: 50/60 Hz Electric plug: Type B (USA, CA, JP, MX)
PLASMABIOTICS
Endoscope clean-storage system| Primary Device ID | 03701354400115 |
| NIH Device Record Key | 3f576642-e5d3-438c-99d5-9cb862897a36 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PlasmaTYPHOON |
| Version Model Number | Typhoon-V2TD120 |
| Company DUNS | 262972663 |
| Company Name | PLASMABIOTICS |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | true |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Device Dimensions
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
| Length | 50 Centimeter |
| Width | 50 Centimeter |
| Height | 50 Centimeter |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
| Storage Environment Temperature | Between 15 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 0.9 Inches of Mercury and 1.1 Inches of Mercury |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701354400115 [Primary] |
FDA Product Code
| LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
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 | 2021-05-20 |
| Device Publish Date | 2021-05-12 |
Devices Manufactured by PLASMABIOTICS
| 03701354404403 - Media roll with 1100 labels for TSC printer | 2021-05-24 Media roll with 1100 labels for TSC printer |
| 03701354404502 - Thermal transfer ribbon 74 m for TSC printer | 2021-05-24 Thermal transfer ribbon 74 m for TSC printer |
| 03701354404601 - Self-adhesive bar-code, 10 units | 2021-05-24 Self-adhesive bar-code, 10 units |
| 03701354404700 - Coplex bar-code (to attach), 10 units | 2021-05-24 Coplex bar-code (to attach), 10 units |
| 03701354404809 - Stainless steel bar-code (to attach), 10 units | 2021-05-24 Stainless steel bar-code (to attach), 10 units |
| 03701354404908 - Demo Flight case | 2021-05-24 Demo Flight case |
| 03701354405004 - Endoscope surrogate (channel system) and its connection set for demonstration pu | 2021-05-24 Endoscope surrogate (channel system) and its connection set for demonstration purposes |
| 03701354405103 - Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U | 2021-05-24 Silicone connection set for ultrasound bronchoscopes PENTAX EB19-J10U |
Trademark Results [PlasmaTYPHOON]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PLASMATYPHOON 97387539 not registered Live/Pending |
PLASMABIOTICS 2022-04-28 |
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