| Primary Device ID | 05713708000221 |
| NIH Device Record Key | 5d8f5f2d-0a4d-4abc-a612-496e69bc993e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Lehiso |
| Version Model Number | 214714 |
| Company DUNS | 312009710 |
| Company Name | Lehiso A/S |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | MR Unsafe |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +4539177100 |
| eand@demant.com | |
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| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05713708000221 [Primary] |
| KLW | Masker, tinnitus |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-05-19 |
| Device Publish Date | 2020-05-11 |
| 05713708000153 | REMOTELINK 1.10 IOS |
| 05713708000146 | REMOTELINK 1.10 ANDROID |
| 05713708000122 | REMOTELINK 1.9 ANDROID |
| 05713708000115 | REMOTELINK 1.9 IOS |
| 05713708000078 | REMOTELINK 1.8 ANDROID |
| 05713708000054 | REMOTELINK 1.8 IOS |
| 05713708000036 | REMOTELINK 1.4 IOS |
| 05713708000012 | REMOTELINK 1.4 ANDROID |
| 05713708000221 | REMOTELINK 2.1.0 ANDROID |
| 05713708000214 | REMOTELINK 2.1.0 IOS |
| 05713708000184 | REMOTELINK 2.0 ANDROID |
| 05713708000177 | REMOTELINK 2.0 IOS |