| Primary Device ID | 10850068519030 |
| NIH Device Record Key | f08be4a7-32e5-46dd-ab97-d53abc057b67 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAM Medical |
| Version Model Number | IO700 |
| Company DUNS | 017535668 |
| Company Name | ZIEN MEDICAL TECHNOLOGIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| Expiration Date | false |
| 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 | 00850068519033 [Primary] |
| GS1 | 10850068519030 [Package] Contains: 00850068519033 Package: Case [10 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-06-11 |
| Device Publish Date | 2025-06-03 |
| 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. |
| 10850068519221 | SAM IO - Adaptor |
| 10850068519030 | SAM IO Driver |
| 00850068519026 | SAM IO Stabilizer |