| Primary Device ID | 00865351000310 |
| NIH Device Record Key | dbfebcf3-0055-47a4-8097-2c29848be082 |
| Commercial Distribution Discontinuation | 2019-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | MIDASystem™ |
| Version Model Number | IV-ASY-0450 |
| Catalog Number | IV-ASY-0450 |
| Company DUNS | 116708692 |
| Company Name | INTRAVU, INC. |
| 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 |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Handling Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Storage Environment Temperature | Between -18 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00865351000310 [Primary] |
| GCJ | Laparoscope, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-03-27 |
| Device Publish Date | 2019-01-18 |
| 00850023905031 - 30 SideVu-60 | 2023-07-11 Kit containing 60mm Scope and 60mm Cannula (2x), 60mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile |
| 00850023905048 - 30 SideVu-90 | 2023-07-11 Kit containing 90mm Scope and 90mm Cannula (2x), 90mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, sterile |
| 00850023905055 - 30 SideVu-120 | 2023-07-11 Kit containing 120mm Scope and 120mm Cannula (2x), 120mm Trocar (2x), and Stopcock (2x). 30 SideVu is a 30deg miniaturized, ster |
| 00850023905000 - AccessVu 90 | 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 90. Kit contains 90mm cannula, 90mm trocar, cannula cap and stopcock. |
| 00850023905017 - AccessVu 60 | 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 60. Kit contains 60mm cannula, 60mm trocar, cannula cap and stopcock. |
| 00850023905024 - AccessVu 120 | 2021-10-25 Disposable accessory kit to be used with IntraVu Scope 120. Kit contains 120mm cannula, 120mm trocar, cannula cap and stopcock. |
| 00865351000389 - TabletVu | 2021-10-25 TabletVu is a reusable visualization system for use with the IntraVu Scope. |
| 00865351000303 - MIDAScope™ - 120 and Introducer Kit | 2020-03-27 Kit containing 120mm Scope and 120mm Cannula, 120mm Trocar, and Stopcock. MIDAScope™ is a miniaturized, sterile, single-use di |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MIDASYSTEM 87433499 not registered Dead/Abandoned |
IntraVu, Inc. 2017-05-02 |