| Primary Device ID | 05056080500058 |
| NIH Device Record Key | e82695be-d4bb-4d24-8b2c-aa3f8dafc7c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | R30852601 |
| Company DUNS | 232600853 |
| Company Name | REMEL EUROPE LIMITED |
| 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 | 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05056080500058 [Primary] |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-24 |