| Primary Device ID | 00822045001503 |
| NIH Device Record Key | 9e4f61d2-0d69-4fed-9a6e-b07322e219ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAM ThoraSite® |
| Version Model Number | TS200-1P |
| Company DUNS | 131084188 |
| Company Name | SAM Medical Products |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com | |
| Phone | 503-639-5474 |
| regulatory@sammedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00822045001503 [Primary] |
| GS1 | 10822045001500 [Package] Package: Inner Pack [25 Units] In Commercial Distribution |
| GBX | Catheter, Irrigation |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-22 |
| Device Publish Date | 2025-12-12 |
| 40822045001129 | ThoraSite 25-Pack |
| 30822045001122 | ThoraSite 5-Pack |
| 00822045001503 | SAM ThoraSite® |