Identity
- Trade Name
- XTR FDA UDI
- Generic Name
- Electrocardiography monitoring system receiver FDA UDI
- Device Name
- 16 Patient Telemetry Receiver FDA UDI
- Model / Reference
- 96280 FDA UDI
- Description
- 16 Patient Telemetry Receiver FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 10841522102707 FDA UDI
- 510(k) Number
- K141156 FDA UDI
- FDA Product Code
- MLD FDA UDIDSI FDA UDIMHX FDA UDIMSX FDA UDI
- GMDN Term
- Electrocardiography monitoring system receiver FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1025 FDA UDI870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrocardiography monitoring system receiver
Xtr by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K141156 also covers:
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Spacelabs Healthcare — SPACELABS HEALTHCARE (WASHINGTON), INC
- Ultraview SL® — SPACELABS HEALTHCARE (WASHINGTON), INC
- XTR — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit — SPACELABS HEALTHCARE (WASHINGTON), INC
- Xhibit Telemetry Receiver — SPACELABS HEALTHCARE (WASHINGTON), INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Spacelabs Healthcare (washington), Inc
Sources (1)
- FDA UDI 06552404-36ad-4ae6-8e77-ae3f85fdc8e0 36 fields · synced Jun 8, 2026