| Primary Device ID | M99597580018L1 |
| NIH Device Record Key | 866af935-4893-4595-82c5-a4f7e663a584 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BFR Throwing Cuff, Reusable |
| Version Model Number | 9-7580-018L |
| Company DUNS | 251078945 |
| Company Name | Delfi Medical Innovations 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 6047420600 |
| info@delfimedical.com | |
| Phone | 6047420600 |
| info@delfimedical.com | |
| Phone | 6047420600 |
| info@delfimedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M99597580018L1 [Primary] |
| KCY | Tourniquet, Pneumatic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-22 |
| Device Publish Date | 2026-01-14 |
| M99597580021R1 | Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring |
| M99597580018R1 | Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring |
| M99597580018L1 | Delfi BFR Throwing Cuffs are specifically designed for use with Delfi’s PTS for BFR, featuring |