Fukuda Vital Signs Monitor

GUDID 00860002604404

Fukuda Denshi USA, Inc. Spot check Vital Signs Monitor

FUKUDA DENSHI USA, INC.

General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor General-purpose multi-parameter bedside monitor

• Primary Device ID: 00860002604404
• NIH Device Record Key: fef6b3f1-217e-42e9-a9ae-42a6baedc9e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fukuda Vital Signs Monitor
• Version Model Number: Fukuda VSM
• Company DUNS: 199040556
• Company Name: FUKUDA DENSHI USA, INC.
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com
• Phone: 8003656668
• Email: customerservice@fukudaamerica.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860002604404 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182821

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-11-10
• Device Publish Date: 2020-06-05