patient monitor

GUDID 06932562310331

Guangdong Biolight Meditech Co., Ltd.

General-purpose multi-parameter bedside monitor

• Primary Device ID: 06932562310331
• NIH Device Record Key: 5b0ef800-35d9-4a01-9134-278e83a1bd70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: patient monitor
• Version Model Number: M9000
• Company DUNS: 530120146
• Company Name: Guangdong Biolight Meditech Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• 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	06932562310331 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100046

FDA Product Code

• MHX: Monitor, Physiological, Patient(With 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: 2020-08-18
• Device Publish Date: 2020-08-10

On-Brand Devices [patient monitor]

• 06932562310232: M8000
• 06932562310218: Q7
• 06932562310201: Q3
• 06932562310195: AnyView A3
• 06932562310188: AnyView A5
• 06932562310171: AnyView A8
• 06932562310164: M7000
• 06932562310140: The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Ra
• 06932562310133: The Monitor is used to monitor patient’s physiological parameters such as ECG、Respiration Ra
• 06932562310126: The vital signs monitor is intended to be used for monitoring, displaying, reviewing, storing an
• 06932562310119: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310102: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310096: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310089: The Monitor is intended to be used for monitoring, displaying, reviewing, storing and alarming o
• 06932562310331: M9000