SmartLinx Vitals Plus

GUDID 03615040000384

VitalsPlus NiBP Suntech Thermometer Exergen

CAPSULE TECHNOLOGIE

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: 03615040000384
• NIH Device Record Key: 7d4c8b79-d493-4df8-8fe4-0cdccd8cccfd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmartLinx Vitals Plus
• Version Model Number: SL-VP-BPAP-HW
• Company DUNS: 536805245
• Company Name: CAPSULE TECHNOLOGIE
• 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	03615040000384 [Previous]
GS1	03615040000469 [Primary]

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: 2020-01-13
• Device Publish Date: 2018-04-09

On-Brand Devices [SmartLinx Vitals Plus]

• 03615040000391: VitalsPlus NiBP Suntech Oximeter Masimo Thermometer Exergen
• 03615040000384: VitalsPlus NiBP Suntech Thermometer Exergen
• 03615040000377: VitalsPlus NiBP Suntech Oximeter Masimo
• 03615040000360: VitalsPlus NiBP Suntech