| Primary Device ID | 04251204326168 |
| NIH Device Record Key | bce9ac0a-945e-4b13-8c66-82aec8cb4e5d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MALDI Biotyper sirius CA System |
| Version Model Number | 1890132 |
| Catalog Number | 1890132 |
| Company DUNS | 318387958 |
| Company Name | Bruker Daltonik GmbH |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(877)442-2231 |
| ms.support.us@bruker.com |
| Storage Environment Temperature | Between 50 Degrees Fahrenheit and 104 Degrees Fahrenheit |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04251204326168 [Primary] |
| PEX | System, mass spectrometry, maldi tof, microorganism identification, cultured isolates |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-09 |
| Device Publish Date | 2019-07-01 |
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| 04251204326168 - MALDI Biotyper sirius CA System | 2019-07-09Biotyper system for clinical use in the USA, with smartbeam laser. |
| 04251204326168 - MALDI Biotyper sirius CA System | 2019-07-09 Biotyper system for clinical use in the USA, with smartbeam laser. |
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