Everion+ System

GUDID 08885018690007

Everion+ System

BIOFOURMIS SINGAPORE PTE. LTD.

Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 08885018690007
• NIH Device Record Key: 50865a7c-eae1-4d97-aa67-e8de36953d93
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everion+ System
• Version Model Number: EVRPLUS-G
• Company DUNS: 659253421
• Company Name: BIOFOURMIS SINGAPORE PTE. LTD.
• 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: true
• 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	08885018690007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213863

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-30
• Device Publish Date: 2023-03-22

Devices Manufactured by BIOFOURMIS SINGAPORE PTE. LTD.

• 08885018690090 - Everion+ System Adjustable Armband: 2023-05-10
• 08885018690083 - Everion+ System Adjustable Armband: 2023-05-10
• 08885018690007 - Everion+ System: 2023-03-30Everion+ System
• 08885018690007 - Everion+ System: 2023-03-30 Everion+ System