Primary Device ID | 04580137732617 |
NIH Device Record Key | 4a38a631-5061-4180-b955-ac0e3c461b18 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | MACHIDA |
Version Model Number | RLED-30 |
Company DUNS | 690662549 |
Company Name | MACHIDA ENDOSCOPE CO.,LTD. |
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 | 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 |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Handling Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Storage Environment Temperature | Between 10 Degrees Celsius and 35 Degrees Celsius |
Storage Environment Humidity | Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Issuing Agency | Device ID |
---|---|
GS1 | 04580137732617 [Primary] |
NTN | Led Light Source |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-04-04 |
Device Publish Date | 2025-03-27 |
04580137732518 | ENT-2L |
04580137732501 | ENT-3C |
04580137730217 | ENT-4L |
04580137730200 | ENT-3L |
04580137733041 | VSP-2000 |
04580137733034 | ENT-30VE |
04580137730279 | LY-CS30 |
04580137732617 | RLED-30 |
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 |