| Primary Device ID | 04987562488506 | 
| NIH Device Record Key | 4a1c2ef9-7bd0-4337-b416-6def69f27e55 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | UDM (Urinalysis Data Manager) | 
| Version Model Number | 1.X | 
| Catalog Number | AB364503 | 
| Company DUNS | 690664461 | 
| Company Name | SYSMEX CORPORATION | 
| 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 | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | |
| Phone | +1(888)879-7644 | 
| crc@sysmex.com | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 04987562488506 [Primary] | 
| OUG | Medical Device Data System | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-03-24 | 
| Device Publish Date | 2025-03-14 | 
| 04987562518654 - Automated Blood Coagulation Analyzer CS-5100 | 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use. | 
| 04987562518661 - Automated Blood Coagulation Analyzer CS-2500 | 2025-09-19 A fully automated blood coagulation analyzer intended for in vitro diagnostic use. | 
| 04987562518678 - Automated Blood Coagulation Analyzer CA-600 series CA-620 | 2025-09-19 A fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use | 
| 04987562518685 - Automated Blood Coagulation Analyzer CA-600 series CA-660 | 2025-09-19 a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use. | 
| 04987562499687 - Automated Blood Coagulation Analyzer CN-6000 | 2025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator | 
| 04987562518630 - Automated Blood Coagulation Analyzer CN-6000 | 2025-09-01 The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laborator | 
| 04987562488506 - UDM (Urinalysis Data Manager) | 2025-03-24 | 
| 04987562488506 - UDM (Urinalysis Data Manager) | 2025-03-24 | 
| 04987562508440 - XQ-520 XQ-Series Automated Hematology Analyzer | 2025-01-22 The XQ-Series analyzer (XQ-520) is a quantitative multi-parameter automated hematology analyzer intended for in vitro diagnostic |