| Primary Device ID | 15099590671990 |
| NIH Device Record Key | 3b124a34-fe5c-40bd-a07f-e785fc8891a6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DxH 500 Series Calibrator |
| Version Model Number | B36880 |
| Company DUNS | 985071975 |
| Company Name | BECKMAN COULTER IRELAND INC. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | true |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 15099590671990 [Primary] |
| JPK | Mixture, Hematology Quality Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-09 |
| Device Publish Date | 2019-05-01 |
| 10837461002031 - iQ®200 | 2023-10-13 iQ Precision Kit |
| 10837461002147 - iQ®200 | 2023-10-13 iQ® Calibrator Pack |
| 10837461002178 - iQ®200 | 2023-10-13 iQ® Control/Focus Set (NA/INTL) |
| 10837461002239 - Iris® | 2023-10-13 Iris® Diluent Pack (NA) |
| 10837461002260 - Iris® | 2023-10-13 Iris® System Cleanser Pack (NA/INTL) |
| 10837461002307 - iQ®200 | 2023-10-13 iQ® Body Fluids Lysing Reagent (NA/INTL) |
| 10837461002345 - iQ®200 | 2023-10-13 iQ® Body Fluids Controls-Level I and Level II (NA/INTL) |
| 10837461002376 - iQ®200 | 2023-10-13 iQ® Lamina™ Case of 2 x 7 L |