| Primary Device ID | 20822045000302 |
| NIH Device Record Key | 1862881d-2953-4618-947b-ee303d5c15a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SAM IO Intraosseous Access System |
| Version Model Number | IO740-1P-EN |
| 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 | 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 | 00822045000308 [Primary] |
| GS1 | 20822045000302 [Package] Contains: 00822045000308 Package: Case [30 Units] In Commercial Distribution |
| KMK | Device, Intravascular Catheter Securement |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2023-09-13 |
| Device Publish Date | 2020-05-28 |
| 20822045000289 | SAM IO - 25mm Needle Assembly - 5 Pack |
| 30822045000293 | SAM IO - 45mm Needle Assembly - 5 Pack |
| 20822045000272 | SAM IO - 15mm Needle Assembly - 5 Pack |
| 10822045000329 | SAM IO - Adaptor - 1 Pack |
| 20822045000296 | SAM IO - 45mm Needle Assembly - 1 Pack |
| 10822045000282 | SAM IO - 25mm Needle Assembly - 1 Pack |
| 00822045000278 | SAM IO - 15 mm Needle Assembly - 1 Pack |
| 10822045000244 | SAM IO - Driver - 1 Pack |
| 30822045000309 | SAM IO Stabilizer - 5 Pack |
| 20822045000302 | SAM IO Stabilizer - 1 Pack |