RONDO
GUDID 09008737306250
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Cochlear implant system| Primary Device ID | 09008737306250 |
| NIH Device Record Key | 6ad8c8a5-22a7-4527-addd-c23c4e331418 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RONDO |
| Version Model Number | RONDO ExtKit grey |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | false |
| 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 |
Customer Support Contacts
| 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 | |
| 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 |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Storage Environment Temperature | Between 0 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | 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 Temperature | Between 32 Degrees Fahrenheit and 122 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1060 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737306250 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Approval: P000025
FDA Product Code
| MCM | IMPLANT, COCHLEAR |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-10-19 |
| Device Publish Date | 2014-12-03 |
On-Brand Devices [RONDO]
| 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 |
Trademark Results [RONDO]
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 |
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