| Primary Device ID | 05713315005992 |
| NIH Device Record Key | b5e3dee0-9cf4-43af-b5bb-8c9ccc5cb546 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Natus |
| Version Model Number | 8-61-20100 |
| Company DUNS | 306633756 |
| Company Name | Gn Otometrics A/S |
| 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 | true |
| Serial Number | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713315005992 [Primary] |
| ERA | Otoscope |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-22 |
| Device Publish Date | 2020-09-14 |
| 05713315008436 | 1093 Desktop Cradle |
| 05713315008429 | 1093 HS3 Headset |
| 05713315005992 | 1093, DESKTOP CRADLE, ACCESSORY |
| 05713315008627 | Patient Responder (Blue) |
| 05713315008610 | Patient Responder (Black) |
| 05713315008603 | Patient Responder (Red) |
| 05713315008672 | Acculink Software |
| 05713315008658 | AccuScreen PRO Ear Couplers (25 sets of 2) |
| 05713315008641 | AccuScreen Ear Couplers (25 sets of 2) |
| 05713315008689 | 1053 Freefit Charger |
| 05713315009051 | Aurical Freefit without charger (Japan only) |
| 05713315009044 | Aurical Freefit without charger (China only) |
| 05713315009037 | Aurical Freefit with charger (China only) |
| 05713315005893 | HB 8 kHz headset, jack connector |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() NATUS 87624187 5453399 Live/Registered |
Natus Medical Incorporated 2017-09-27 |
![]() NATUS 86540434 4812806 Live/Registered |
Natus Medical Incorporated 2015-02-19 |
![]() NATUS 85893616 not registered Dead/Abandoned |
Lestat, Ofel 2013-04-03 |
![]() NATUS 85653367 not registered Dead/Abandoned |
RagTrade Industries, LLC 2012-06-15 |
![]() NATUS 85437060 4153501 Live/Registered |
Natus Medical Incorporated 2011-09-30 |
![]() NATUS 74073532 1637520 Live/Registered |
Natus Medical Inc. 1990-06-28 |
![]() NATUS 73834858 1635226 Dead/Cancelled |
NATUS CORPORATION 1989-10-30 |