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SmartLinx Vitals Plus

FDA UDI

Class II (US FDA UDI)

by Philips North America LLC

Identity

Trade Name
SmartLinx Vitals Plus FDA UDI
Generic Name
Patient monitoring system module, interfacing FDA UDI
Device Name
VitalsPlus NiBP Suntech Thermometer Exergen FDA UDI
Model / Reference
SL-VP-BPAP-HW FDA UDI
Description
VitalsPlus NiBP Suntech Thermometer Exergen FDA UDI

Identifiers

Primary DI / UDI-DI
03615040000186 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
Not 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
MRI Safety
MR Unsafe FDA UDI

SmartLinx Vitals Plus by Philips North America LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K151071 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Philips North America LLC

Sources (1)

  • FDA UDI 66c6e939-a907-4150-819d-6ffb32ab9a41 35 fields · synced Jun 8, 2026