Vital Signs Patient Monitor

GUDID 00616784084015

Vital Signs Patient Monitor - V6 w/ BLT sp02, BP, Temp

DYNAREX CORPORATION

Patient monitoring system module, multifunction

• Primary Device ID: 00616784084015
• NIH Device Record Key: 3433be96-8fb5-48db-add7-f694420a19e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Signs Patient Monitor
• Version Model Number: 10840
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: true
• 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	00616784084015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153135

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-10
• Device Publish Date: 2020-02-01

On-Brand Devices [Vital Signs Patient Monitor]

• 00616784084114: Vital Signs Patient Monitor - V Touch screen
• 00616784084015: Vital Signs Patient Monitor - V6 w/ BLT sp02, BP, Temp