| Primary Device ID | M99592500002BFR1 |
| NIH Device Record Key | 5575ed25-f16e-4713-901a-064cd21d3915 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTS for BFR Generation 3 - Dual Channel System |
| Version Model Number | 9-2500-002BFR |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com | |
| Phone | 16047420600 |
| info@delfimedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M99592500002BFR1 [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 | 2025-06-25 |
| Device Publish Date | 2025-06-17 |
| M99592500002BFR1 - PTS for BFR Generation 3 - Dual Channel System | 2025-06-25The Delfi PTS for BFR Gen 3 is intended to be used by qualified medical professionals to exert enough pressure on the arterial blood flow in a limb to produce a bloodless operating field. |
| M99592500002BFR1 - PTS for BFR Generation 3 - Dual Channel System | 2025-06-25 The Delfi PTS for BFR Gen 3 is intended to be used by qualified medical professionals to exert enough pressure on the arterial b |
| M995979500181 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
| M995979500241 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
| M995979500341 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
| M995979500441 - Matching Limb Protection Sleeves - Easi-Fit BFR | 2024-02-05 Delfi Matching Limb Protection Sleeves (MLPS) help protect the patient’s limb from possible wrinkling, pinching and shearing o |
| M995601000212001 - PTS Hose Set | 2023-06-02 Hose set for use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00 |
| M995601000234001 - Calibration Hose Set | 2023-06-02 Calibration Hose set for the use with PTS ii Portable Tourniquet System, REF: 60-1000-101-00 |
| M995922000243 - PTS Hose Set - Single (Female Connector) | 2023-06-02 PTS Hose Set (Female metal connector) for use with Personalized Tourniquet System (PTS) for Blood Flow Restriction (BFR) |