SmartLinx Vitals Plus

GUDID 03615040000117

VitalsPlus NiBP Suntech Oximeter Masimo with RollStand

Philips North America LLC

Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing Patient monitoring system module, interfacing

• Primary Device ID: 03615040000117
• NIH Device Record Key: 781424c0-dc78-4960-bf1e-9f41e9b470a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLinx Vitals Plus
• Version Model Number: SL-VP-BPAP-HW
• Company DUNS: 001291111
• Company Name: Philips North America LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	03615040000117 [Previous]
GS1	03615040000179 [Primary]
GS1	03615040000414 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151071

FDA Product Code

• MWI: Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-08-14
• Device Publish Date: 2018-04-09

On-Brand Devices [SmartLinx Vitals Plus]

• 03615040003088: Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
• 03615040003071: Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
• 03615040003064: Vitals Plus Backpack Thermometer Exergen
• 03615040003057: Vitals Plus Backpack Oximeter Nellcor Thermometer Filac
• 03615040003040: Vitals Plus Backpack Oximeter Masimo Thermometer Filac
• 03615040003033: Vitals Plus Backpack Thermometer Filac
• 03615040003026: Vitals Plus Backpack Oximeter Nellcor
• 03615040003019: Vitals Plus Backpack Oximeter Masimo
• 03615040003002: Vitals Plus Backpack
• 03615040001480: Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
• 03615040001473: Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
• 03615040001466: Vitals Plus Backpack Thermometer Exergen
• 03615040001459: Vitals Plus Backpack Oximeter Nellcor Thermometer Filac
• 03615040001442: Vitals Plus Backpack Oximeter Masimo Thermometer Filac
• 03615040001435: Vitals Plus Backpack Thermometer Filac
• 03615040001428: Vitals Plus Backpack Oximeter Nellcor
• 03615040001411: Vitals Plus Backpack Oximeter Masimo
• 03615040001404: Vitals Plus Backpack
• 03615040002135: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Exergen
• 03615040002142: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Filac
• 03615040002128: Vitals Plus NiBP Suntech Alarm hub Oximeter Nellcor
• 03615040002111: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Exergen
• 03615040002098: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Filac
• 03615040002074: Vitals Plus NiBP Suntech Alarm hub Oximeter Nellcor
• 03615040002104: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Exergen
• 03615040002081: VitalsPlus NiBP Suntech Alarm hub Oximeter Nellcor Thermometer Filac
• 03615040002067: Vitals Plus NiBP Suntech Alarm hub Oximeter Nellcor
• 03615040000919: Vitals Plus Backpack Oximeter Nellcor Thermometer Exergen
• 03615040000902: Vitals Plus Backpack Oximeter Masimo Thermometer Exergen
• 03615040000896: Vitals Plus Backpack Thermometer Exergen
• 03615040000889: Vitals Plus Backpack Oximeter Nellcor Thermometer Filac
• 03615040000872: Vitals Plus Backpack Oximeter Masimo Thermometer Filac
• 03615040000865: Vitals Plus Backpack Thermometer Filac
• 03615040000858: Vitals Plus Backpack Oximeter Nellcor
• 03615040000841: Vitals Plus Backpack Oximeter Masimo
• 03615040000834: Vitals Plus Backpack
• 03615040001312: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo Thermometer Exergen
• 03615040001305: Vitals Plus NiBP Suntech Alarm hub Thermometer Exergen
• 03615040001299: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo Thermometer Filac
• 03615040001282: Vitals Plus NiBP Suntech Alarm hub Thermometer Filac
• 03615040001275: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo
• 03615040001268: Vitals Plus NiBP Suntech Alarm hub
• 03615040001251: Vitals Plus NiBP Suntech Oximeter Masimo Thermometer Filac
• 03615040001244: Vitals Plus NiBP Suntech Thermometer Filac
• 03615040001237: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo Thermometer Exergen
• 03615040001220: Vitals Plus NiBP Suntech Alarm hub Thermometer Exergen
• 03615040001213: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo Thermometer Filac
• 03615040001206: Vitals Plus NiBP Suntech Alarm hub Thermometer Filac
• 03615040001190: Vitals Plus NiBP Suntech Alarm hub Oximeter Masimo
• 03615040001183: Vitals Plus NiBP Suntech Alarm hub