| Primary Device ID | 00860412001572 |
| NIH Device Record Key | 48d60125-ad7e-464a-be71-69713fed4462 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAM Medical |
| Version Model Number | RT200-G1-EN |
| Catalog Number | RT200-G1-EN |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | MR Conditional |
| 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 | 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 | 00860412001572 [Primary] |
| GS1 | 10860412001579 [Package] Package: Shipper [5 Units] In Commercial Distribution |
| JOL | Catheter And Tip, Suction |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-18 |
| Device Publish Date | 2024-11-08 |
| 00850068519118 | The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis |
| 00850068519088 | The SAM IO™ Intraosseous Access System provides intraosseous access in the proximal tibia, dis |
| 00850068519057 | The SAM IO Intraosseous Access System provides intraosseous access in the proximal tibia, distal |
| 00860412001572 | Repositionable Chest Tube (RCT) catheters intended for use in pleural fluid drainage. |