| Primary Device ID | M995601000101001 |
| NIH Device Record Key | 3eda6893-ad07-449c-a1b4-21a74ce05f2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PTSii Personalized Tourniquet System |
| Version Model Number | 60-1000-101-00 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M995601000101001 [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 | 2022-12-15 |
| Device Publish Date | 2022-12-07 |
| M995922000011 | (Single Channel, Single Port System) The Delfi PTS ii Portable Tourniquet System is intended to |
| M995601000101001 | The PTS ii Portable Tourniquet System is intended to be used by qualified medical professionals |