MACHIDA
GUDID 04580137733041
MACHIDA ENDOSCOPE CO.,LTD.
Endoscopic control/video-imaging system| Primary Device ID | 04580137733041 |
| NIH Device Record Key | 3383b985-07fd-44ee-9412-45dd1a5bda9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MACHIDA |
| Version Model Number | VSP-2000 |
| Company DUNS | 690662549 |
| Company Name | MACHIDA ENDOSCOPE CO.,LTD. |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04580137733041 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K821182
FDA Product Code
| EQN | Laryngoscope, Nasopharyngoscope |
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 | 2022-08-16 |
| Device Publish Date | 2022-08-08 |
On-Brand Devices [MACHIDA]
| 04580137732518 | ENT-2L |
| 04580137732501 | ENT-3C |
| 04580137730217 | ENT-4L |
| 04580137730200 | ENT-3L |
| 04580137733041 | VSP-2000 |
| 04580137733034 | ENT-30VE |
| 04580137730279 | LY-CS30 |
Trademark Results [MACHIDA]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MACHIDA 86703985 not registered Dead/Abandoned |
Machida Incorporated 2015-07-24 |
 MACHIDA 72417869 0971439 Live/Registered |
KABUSHIKI KAISHA MACHIDA SEISAKUSHO 1972-03-09 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.