| Primary Device ID | 09008737350697 |
| NIH Device Record Key | 8392721f-cfb7-4645-986e-2f3293b044d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RONDO |
| Version Model Number | 35069 |
| Catalog Number | 35069 |
| Company DUNS | 300764032 |
| Company Name | Med-El Elektromedizinische Geräte Gesellschaft m.b.H. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| 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 |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Handling Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 10 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -4 Degrees Fahrenheit and 140 Degrees Fahrenheit |
| Storage Environment Temperature | Between -20 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737350697 [Primary] |
| MCM | Implant, Cochlear |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2018-06-21 |
| 09008737350710 | RONDO Control Unit ebony, Service Pool (SP) |
| 09008737350703 | RONDO Control Unit grey, Service Pool (SP) |
| 09008737350697 | RONDO Control Unit creme, Service Pool (SP) |
| 09008737350680 | RONDO Control Unit anthracite, Service Pool (SP) |
| 09008737306274 | RONDO ExtKit creme |
| 09008737306267 | RONDO ExtKit ebony |
| 09008737306250 | RONDO ExtKit grey |
| 09008737306243 | RONDO ExtKit anthr. |
| 09008737084806 | RONDO Battery Pack ebony |
| 09008737084790 | RONDO Battery Pack grey |
| 09008737084783 | RONDO Battery Pack creme |
| 09008737084776 | RONDO Control Unit ebony |
| 09008737084769 | RONDO Control Unit grey |
| 09008737084752 | RONDO Control Unit creme |
| 09008737082864 | RONDO Battery Pack anthracite |
| 09008737082840 | RONDO Control Unit anthracite |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() RONDO 97229209 not registered Live/Pending |
Rondo Energy, Inc. 2022-01-20 |
![]() RONDO 90074094 not registered Live/Pending |
Rondo Beverages LLC 2020-07-26 |
![]() RONDO 88845641 not registered Live/Pending |
ARGOSDYNE Co., Ltd. 2020-03-24 |
![]() RONDO 87882423 not registered Live/Pending |
Rondo Building Services Pty Limited 2018-04-18 |
![]() RONDO 87502276 5380177 Live/Registered |
ORLENKO MAKSYM 2017-06-23 |
![]() RONDO 87421248 not registered Dead/Abandoned |
WET 2017-04-22 |
![]() RONDO 85628339 4911707 Live/Registered |
Dysonics Corporation 2012-05-17 |
![]() RONDO 85169910 4538011 Live/Registered |
MED-EL Elektromedizinische Geräte Ges.m.b.H. 2010-11-05 |
![]() RONDO 79402020 not registered Live/Pending |
Polykemi AB 2024-07-04 |
![]() RONDO 79387453 not registered Live/Pending |
Polykemi AB 2023-12-15 |
![]() RONDO 79374630 not registered Live/Pending |
Rondo Burgdorf AG 2023-05-15 |
![]() RONDO 79297082 not registered Live/Pending |
SZYMON KOBYLINSKI 2020-08-19 |