| Primary Device ID | 00850035498446 |
| NIH Device Record Key | 7fb171c5-596f-4323-b21f-82cc68525b01 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Progen PRP Advantage |
| Version Model Number | F5PG020 |
| Company DUNS | 005677967 |
| Company Name | Bellus Medical, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850035498446 [Primary] |
| ORG | Platelet And Plasma Separator For Bone Graft Handling |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-02 |
| Device Publish Date | 2022-04-22 |
| 00850035498446 | Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit |
| 00850035498439 | Progen PRP Advantage Kits - 15 ml PRP tubes and Blood Draw Kit |
| 00850035498422 | Progen PRP Advantage Kits - 30 ml PRP Tubes and Blood Draw Kit |
| 00850035498415 | Progen PRP Advantage Kits - 15 ml PRP Tubes and Blood Draw Kit |
| 00850035498408 | 30 ml Blood Draw Kits |
| 00850035498392 | 15 mL Blood Draw Kit - Single |