| Primary Device ID | 08800003455928 |
| NIH Device Record Key | 085adbc3-9570-488a-b2c0-c5951c91d763 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mediana Co., Ltd. Body Composition Analyzer I20 |
| Version Model Number | I20M-XBXUS |
| Catalog Number | I20M-XBXUS |
| Company DUNS | 687879726 |
| Company Name | Mediana.CO.LTD |
| 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 | false |
| Serial Number | true |
| 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 | 08800003455928 [Primary] |
| PUH | Analyzer, Body Composition, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-31 |
| Device Publish Date | 2023-08-23 |
| 08800003455805 - Mediana Co., Ltd. Body Composition Analyzer I30 | 2023-08-31 |
| 08800003455928 - Mediana Co., Ltd. Body Composition Analyzer I20 | 2023-08-31 |
| 08800003455928 - Mediana Co., Ltd. Body Composition Analyzer I20 | 2023-08-31 |
| 08800003458301 - Mediana Co., Ltd. Body Composition Analyzer I25 | 2023-08-31 |
| 08800003458349 - Mediana Co., Ltd. Body Composition Analyzer I35 | 2023-08-31 |
| 08800003466115 - Mediana Co., Ltd. Body Composition Analyzer I35 | 2023-08-31 |
| 08800003466405 - Mediana Co., Ltd. Body Composition Analyzer I50 | 2023-08-31 |
| 08800003466412 - Mediana Co., Ltd. Body Composition Analyzer I55 | 2023-08-31 |
| 08800003467228 - Mediana Co., Ltd. Body Composition Analyzer I50 | 2023-08-31 |