| Primary Device ID | 00664369000851 |
| NIH Device Record Key | 079602fb-7aa3-4538-8004-0a996eb0d5ce |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Caresphere Workflow Solution |
| Version Model Number | 1.X |
| Company DUNS | 021860424 |
| Company Name | Sysmex America, 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 | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com | |
| Phone | +1(888)879-7639 |
| crc@sysmex.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00664369000851 [Primary] |
| JQP | Calculator/Data Processing Module, For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| 00664369000851 - Caresphere Workflow Solution | 2022-12-15 |
| 00664369000851 - Caresphere Workflow Solution | 2022-12-15 |
| 00664369000639 - Sysmex UF1000i, Automated Urine Particle Analyzer with Urinalysis WAM Software | 2018-07-06 Fully Automated Urine Cell Analyzer UF-1000i UF WAM |