AudioKey 37935
GUDID 09008737379353
AudioKey 2.0
Med-El Elektromedizinische Geräte Gesellschaft m.b.H.
Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software Audiometric/hearing device software| Primary Device ID | 09008737379353 |
| NIH Device Record Key | 5d3754b4-e094-41e7-8d4b-4a1e3c42b897 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AudioKey |
| Version Model Number | 37935 |
| Catalog Number | 37935 |
| 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 | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| 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 | false |
| 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 | |
| Phone | 1-888-633-3524 |
| implants.us@medel.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09008737379353 [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 | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-13 |
| Device Publish Date | 2022-12-05 |
On-Brand Devices [AudioKey]
| 09008737097493 | 09749 |
| 09008737379353 | AudioKey 2.0 |
Trademark Results [AudioKey]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AUDIOKEY 90253595 not registered Live/Pending |
MED-EL Elektromedizinische Geräte Ges.m.b.H. 2020-10-14 |
 AUDIOKEY 86098838 not registered Dead/Abandoned |
MED-EL Elektromedizinische Geräte Ges.m.b.H. 2013-10-23 |
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