| Primary Device ID | 08809988780018 |
| NIH Device Record Key | b8a8d95f-08f2-4d17-876e-64213e5eb6b7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Xandar Kardian Monitoring Sensor XK300-H |
| Version Model Number | XK300-H |
| Company DUNS | 695005778 |
| Company Name | Xandar Kardian Korea 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com | |
| Phone | +1-833-695-2677 |
| support@xkcorp.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809988780018 [Primary] |
| SBO | Bed-Patient Activity Monitoring System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-08 |
| Device Publish Date | 2024-07-31 |
| 08809988780018 - Xandar Kardian Monitoring Sensor XK300-H | 2024-08-08 |
| 08809988780018 - Xandar Kardian Monitoring Sensor XK300-H | 2024-08-08 |
| 08809988780001 - Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300) | 2024-01-29 |