Primary Device ID | 00853419006008 |
NIH Device Record Key | cf3679de-9b12-47b2-a8c4-18256e181940 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | miraDry |
Version Model Number | MD4000-MC |
Company DUNS | 008226764 |
Company Name | MIRAMAR LABS, 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 |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Handling Environment Atmospheric Pressure | Between 55 KiloPascal and 101 KiloPascal |
Storage Environment Temperature | Between -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 -29 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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00853419006008 [Primary] |
MWY | System,Microwave,Hair Removal |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-09-30 |
00853419006039 | bioTip |
00853419006022 | bioTip |
00853419006015 | Handpiece |
00853419006008 | Console |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIRADRY 85774022 4358051 Live/Registered |
MIRADRY, INC. 2012-11-07 |
MIRADRY 85773803 4358050 Live/Registered |
MIRADRY, INC. 2012-11-07 |
MIRADRY 77886437 3998953 Live/Registered |
MIRADRY, INC. 2009-12-04 |
MIRADRY 77886273 3998952 Live/Registered |
MIRADRY, INC. 2009-12-04 |