| Primary Device ID | 00630414312460 |
| NIH Device Record Key | 96eeab58-08d6-4e7f-9136-0b2bd67f3936 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atellica HEMA Cleaner |
| Version Model Number | 11374306 |
| Catalog Number | 11374306 |
| Company DUNS | 064608573 |
| Company Name | Siemens Healthcare Diagnostics Inc. |
| Device Count | 4 |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM | |
| Phone | +1(877)229-3711 |
| CONTACT@SIEMENS-HEALTHINEERS.COM |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Handling Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 18 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00630414289984 [Primary] |
| GS1 | 00630414312460 [Unit of Use] |
| PPM | General purpose reagent |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-16 |
| Device Publish Date | 2026-02-06 |
| 00630414287201 - Atellica HEMA Calibrator | 2026-02-16 AT HEMA Calibrator |
| 00630414289694 - Atellica HEMA 580 Analyzer (SMS ready) | 2026-02-16 Hematology Analyzer |
| 00630414289700 - Atellica HEMA Slidemaker Stainer (SMS) | 2026-02-16 Hematology Slide-maker/stainer |
| 00630414289953 - Atellica HEMA Diluent | 2026-02-16 AT HEMA Diluent 20L |
| 00630414289960 - Atellica HEMA Diluent | 2026-02-16 AT HEMA Diluent |
| 00630414312460 - Atellica HEMA Cleaner | 2026-02-16AT HEMA Cleaner |
| 00630414312460 - Atellica HEMA Cleaner | 2026-02-16 AT HEMA Cleaner |
| 00630414312477 - Atellica HEMA HGB | 2026-02-16 AT HEMA HGB |
| 00630414290003 - Atellica HEMA Baso | 2026-02-16 Atellica HEMA Baso |