SmartLinx Vitals Plus

GUDID 03615040000384

VitalsPlus NiBP Suntech Thermometer Exergen

CAPSULE TECHNOLOGIE

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