FDA UDI
In Commercial Distribution
🇺🇸 United States
Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)
DI: 08809988780049
·
Model: XK300-E
·
Xandar Kardian Korea Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xandar Kardian Vital Sign Monitoring Sensor (Model: XK300-E)
- Primary DI
- 08809988780049
- Version / Model
- XK300-E
- Company Name
- Xandar Kardian Korea Inc.
- Labeler DUNS
- 695005778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-04
- Public Version
- 2
- Public Version Date
- 2025-12-15
- Public Version Status
- Update
- Public Device Record Key
- 478c7a18-a878-4ca7-adf6-994df653f53a
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BZQ | Monitor, Breathing Frequency | Anesthesiology | 868.2375 | 2 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Cardiovascular | 870.2300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65669 | Multiple vital physiological parameter monitoring system, home-use | An assembly of electrically-powered devices designed to be used by a layperson in the home for intermittent or continuous assessment of several vital physiologic parameters [e.g., electrocardiogram (ECG), noninvasive blood pressure (NIBP), pulse rate, temperature, haemoglobin oxygen saturation (SpO2)]. It includes both physiological parameter sensors, probes, and/or electrodes (e.g., ECG electrodes, blood pressure cuff) and processing hardware with dedicated software. It typically incorporates a monitoring screen, but may alternatively be connected to an off-the-shelf device for display; it is not intended to be worn on the body. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08809988780049 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K202464 | 000 |