Nihon Kohden Life Scope G5 Bedside Monitoring System CU-151R

GUDID 04931921002018

Core unit

NIHON KOHDEN CORPORATION

General-purpose multi-parameter bedside monitor

• Primary Device ID: 04931921002018
• NIH Device Record Key: 62b69164-5d41-44bb-9f19-66a79f7e9178
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden Life Scope G5 Bedside Monitoring System
• Version Model Number: CU-151R
• Catalog Number: CU-151R
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN 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: false
• Serial Number: true
• Manufacturing Date: false
• 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	04931921002018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203435

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: 2021-10-05
• Device Publish Date: 2021-09-27

On-Brand Devices [Nihon Kohden Life Scope G5 Bedside Monitoring System]

• 04931921023624: Battery pack (for CU-151R, CU-152R)
• 04931921002360: Handle (for CU-151R, CU-152R)
• 04931921002179: Software Kit (for CU-151R, CU-152R)
• 04931921002100: Rear option board (for CU-151R, CU-152R)
• 04931921002094: Recorder module (for CU-151R, CU-152R)
• 04931921002056: Core Unit
• 04931921002018: Core unit