Everion+ System Adjustable Armband

GUDID 08885018690083

BIOFOURMIS SINGAPORE PTE. LTD.

Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 08885018690083
• NIH Device Record Key: 4270fa13-1ff8-4c28-b427-1287d9efb2c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Everion+ System Adjustable Armband
• Version Model Number: EVR-PD-AAB
• Company DUNS: 659253421
• Company Name: BIOFOURMIS SINGAPORE PTE. LTD.
• Device Count: 4
• 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: true
• Lot Batch: true
• Serial Number: false
• 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	08885018690083 [Unit of Use]
GS1	08885018690106 [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: 2023-05-10
• Device Publish Date: 2023-05-02

On-Brand Devices [Everion+ System Adjustable Armband]

• 08885018690083: EVR-PD-AAB
• 08885018690090: EVR-PD-AAB