| Primary Device ID | 00856893004041 |
| NIH Device Record Key | cf90074f-443b-4f34-90c1-84956284743b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aggreguide |
| Version Model Number | A-100 |
| Company DUNS | 078703793 |
| Company Name | AGGREDYNE, INC. |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00856893004003 [Package] Contains: 00856893004065 Package: Kit [1 Units] In Commercial Distribution |
| GS1 | 00856893004041 [Package] Contains: 00856893004065 Package: Kit [1 Units] In Commercial Distribution |
| GS1 | 00856893004065 [Primary] |
| JOZ | System, Automated Platelet Aggregation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-01 |
| Device Publish Date | 2019-01-01 |
| 00856893004041 | Whole Blood Aggregometer |
| 00856893004027 | AggreDYNE A-100 ADP Assay |