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 |