FDA UDI
In Commercial Distribution
🇺🇸 United States
Xhibit
DI: 10841522120220
·
Model: Xhibit Central
·
SPACELABS HEALTHCARE (WASHINGTON), INC
Product Codes
4
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Xhibit
- Primary DI
- 10841522120220
- Version / Model
- Xhibit Central
- Catalog Number
- 040-1037-04
- Company Name
- SPACELABS HEALTHCARE (WASHINGTON), INC
- Labeler DUNS
- 145581588
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-01-06
- Public Version
- 8
- Public Version Date
- 2023-10-05
- Public Version Status
- Update
- Public Device Record Key
- 705d6ecc-88c7-4b94-822f-80ecf576f595
Device Description
KIT,DUAL ANT,W/PS,PLEN ADC,614,W/2AMP
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- No
- PM Exempt
- No
- Has Serial Number
- No
- 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 |
|---|---|---|---|---|
| MSX | SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS | Cardiovascular | 870.2300 | 2 |
| MHX | MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) | Cardiovascular | 870.1025 | 2 |
| DSI | DETECTOR AND ALARM, ARRHYTHMIA | Cardiovascular | 870.1025 | 2 |
| MLD | MONITOR, ST SEGMENT WITH ALARM | Cardiovascular | 870.1025 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36365 | Electrocardiography monitoring system receiver | An electrically-powered component of an electrocardiograpy telemetric monitoring system designed to wirelessly receive, consolidate, and display electrocardiographic (ECG) signals [sometimes with an additional parameter such as haemoglobin oxygen saturation (SpO2)] from a transmitter connected to a patient, typically ambulatory, for viewing at a receiving location (e.g., central station, bedside monitor). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10841522120220 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K141156 | 000 |