| Primary Device ID | 08056304453419 |
| NIH Device Record Key | 3cd7175a-ae3f-461d-b9a5-b8207443b2f5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MyLabX8 |
| Version Model Number | 100645000 |
| Company DUNS | 437384304 |
| Company Name | ESAOTE SPA |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08056304453419 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2019-12-20 |
| 08056304450852 - MyLab30 Gold Cardiovascular | 2024-11-25 |
| 08056304450869 - MyLab25 Gold | 2024-11-25 |
| 08056304451880 - PA121E | 2024-11-25 |
| 08056304452191 - TE122 | 2024-11-25 correct brand name is TEE122 with two E |
| 08056304453419 - MyLabX8 | 2024-11-25 |
| 08056304453419 - MyLabX8 | 2024-11-25 |
| 08056304454126 - MyLabX8 eXP | 2024-11-25 |
| 08056304455727 - G-scan Open | 2024-07-10 |
| 08056304455741 - O-scan Smart | 2024-07-10 |