Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 QI-152P

GUDID 04931921002117

Side option board (for CU-152R, CU-171R, CU-172R)

NIHON KOHDEN CORPORATION

General-purpose multi-parameter bedside monitor

• Primary Device ID: 04931921002117
• NIH Device Record Key: ca71edf0-7ed7-409d-a807-dabb3e781d3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7
• Version Model Number: QI-152P
• Catalog Number: QI-152P
• Company DUNS: 690568050
• Company Name: NIHON KOHDEN CORPORATION
• 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: 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	04931921002117 [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

Devices Manufactured by NIHON KOHDEN CORPORATION

• 04931921044353 - cap-ONE`: 2024-07-01 Airway adapter for adult and child
• 04931921017524 - NA: 2024-02-02 Receiver unit for ZS, ZM series
• 04931921017159 - CNS-2101 Central Monitor: 2023-11-07 Central Monitor
• 04931921007723 - Nihon Kohden, EEG-1200A Series Neurofax: 2023-10-09 Cart, used with EEG-1200A, works with standard and optional accessories
• 04931921007730 - Nihon Kohden, EEG-1200A Series Neurofax: 2023-10-09 Cart, Compact type, used with EEG-1200A, works with standard and optional accessories
• 04931921017166 - CNS-2101 Central Monitor: 2023-10-09 Central Monitor
• 04931921010235 - cap-ONE: 2023-05-30 cap-ONE Nasal Adapter, Adult
• 04931921010273 - cap-ONE: 2023-05-30 cap-ONE Nasal Adapter, Adult, w/ Oxygen tube