RNS-6803-7460

GUDID 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer

NIHON KOHDEN AMERICA, INC.

Patient monitoring system central station monitor

• Primary Device ID: 00841983104176
• NIH Device Record Key: c7092baa-9e34-47cc-817a-1575bbecedbd
• Commercial Distribution Discontinuation: 2019-01-22
• Commercial Distribution Status: Not in Commercial Distribution
• Version Model Number: RNS-6803-7460
• Catalog Number: RNS-6803-7460
• Company DUNS: 021063219
• Company Name: NIHON KOHDEN AMERICA, INC.
• 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

Customer Support Contacts

• Phone: 18003250283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: 18003250283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: 18003250283
• Email: VitalSignsTechSupport@nihonkohden.com
• Phone: 18003250283
• Email: VitalSignsTechSupport@nihonkohden.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit
• Storage Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -40 Degrees Fahrenheit and 149 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841983104176 [Primary]

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: 2019-02-22
• Device Publish Date: 2019-01-22

Devices Manufactured by NIHON KOHDEN AMERICA, INC.

• 10841983101493 - NA: 2026-02-09 Airway adapter for TG-900P
• 10841983101509 - NA: 2026-02-09 Airway adapter for TG-920P
• 10841983101516 - cap-ONE: 2026-02-09 Nasal adapter for TG-920P (oxygen cannula adjustment)
• 10841983101523 - NA: 2026-02-09 Airway adapter for adult and child
• 10841983101530 - NA: 2026-02-09 Airway adapter for neonate and child, TG-970P
• 10841983101547 - NA: 2026-02-09 Airway adapter for neonate and child
• 10841983101554 - cap-ONE: 2026-02-09 Cap-ONE Mask, Pediatric
• 10841983101561 - cap-ONE: 2026-02-09 Cap-ONE Mask, Infant