Identity
- Trade Name
- SmartLinx Vitals Plus FDA UDI
- Generic Name
- Patient monitoring system module, interfacing FDA UDI
- Device Name
- VitalsPlus NiBP Suntech Thermometer Exergen with RollStand FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo Thermometer Exergen FDA UDIVitalsPlus NiBP Suntech FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo with RollStand FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo Thermometer Exergen with RollStand FDA UDIVitalsPlus NiBP Suntech Thermometer Exergen FDA UDI
- Model / Reference
- SL-VP-BPAP-HW FDA UDI
- Description
- VitalsPlus NiBP Suntech Thermometer Exergen with RollStand FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo Thermometer Exergen FDA UDIVitalsPlus NiBP Suntech FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo with RollStand FDA UDIVitalsPlus NiBP Suntech Oximeter Masimo Thermometer Exergen with RollStand FDA UDIVitalsPlus NiBP Suntech Thermometer Exergen FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03615040000506 FDA UDI03615040000391 FDA UDI03615040000209 FDA UDI03615040000360 FDA UDI03615040000155 FDA UDI03615040000513 FDA UDI03615040000230 FDA UDI03615040000193 FDA UDI03615040000216 FDA UDI03615040000049 FDA UDI03615040000087 FDA UDI03615040000384 FDA UDI
- 510(k) Number
- K151071 FDA UDI
- FDA Product Code
- MWI FDA UDI
- GMDN Term
- Patient monitoring system module, interfacing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDINot 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
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Patient monitoring system module, interfacing
SmartLinx Vitals Plus by Philips North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient monitoring system module, interfacing.
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Cleared under the same submission
K151071 also covers:
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
- SmartLinx Vitals Plus — Philips North America LLC
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Philips North America LLC
Sources (12)
- FDA UDI 4b4024d0-2251-4109-a381-4719b49e8d81 34 fields · synced Jun 8, 2026
- FDA UDI 30da46f9-0498-4d25-ac14-a250d9ddea11 34 fields · synced May 24, 2026
- FDA UDI 0630932f-c05a-4f5e-9722-b8f32fa79f1f 35 fields · synced May 25, 2026
- FDA UDI 8ac87594-09ae-4c63-bc5e-b4172968364d 34 fields · synced May 25, 2026
- FDA UDI efa48129-f776-4a40-8dfa-85d8c6ba9513 35 fields · synced May 25, 2026
- FDA UDI 1cd9de5c-44b6-4c67-b89f-8b72b4abe17c 34 fields · synced May 25, 2026
- FDA UDI 55bd9fca-f1ba-449d-ad56-6a62dae547ac 35 fields · synced May 25, 2026
- FDA UDI 372cd9eb-f7cc-4388-a8d7-440af8505a55 35 fields · synced May 25, 2026
- FDA UDI 5e3d20ef-1208-4079-8159-2de39e64da10 35 fields · synced May 25, 2026
- FDA UDI 4bfeb332-1bd0-45b1-83c3-aef9fec15987 35 fields · synced May 25, 2026
- FDA UDI a32c72cd-9a41-4550-b1f0-e0f0a7406a8f 34 fields · synced May 25, 2026
- FDA UDI 961abddb-6d13-475e-b650-af6eda018aaf 34 fields · synced May 27, 2026