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: Vitals Plus Backpack Oximeter Nellcor Thermometer Filac FDA UDI
Model / Reference: SL-VP-NIBPAH-MON-HW FDA UDI
Description: Vitals Plus Backpack Oximeter Nellcor Thermometer Filac FDA UDI

Identifiers

Primary DI / UDI-DI: 03615040000889 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 UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

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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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: Philips North America LLC

Sources (1)

FDA UDI e569d441-d244-45ce-8aec-d8672ac6a524 33 fields · synced Jun 8, 2026