Current Health Wearable Monnitoring System 40

GUDID 05060526840004

Current Health Wearable Monnitoring System (Gen 1 Wearable)

CURRENT HEALTH LIMITED

General-purpose multi-parameter bedside monitor

• Primary Device ID: 05060526840004
• NIH Device Record Key: 91ff9b4a-bdcc-421a-b02f-a4e9252d0df3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Current Health Wearable Monnitoring System
• Version Model Number: G1
• Catalog Number: 40
• Company DUNS: 220236110
• Company Name: CURRENT HEALTH LIMITED
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060526840004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191272

FDA Product Code

• MSX: System, Network And Communication, Physiological Monitors

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: 2021-09-13
• Device Publish Date: 2021-09-03

On-Brand Devices [Current Health Wearable Monnitoring System]

• 05060526840004: Current Health Wearable Monnitoring System (Gen 1 Wearable)
• 05060526847706: Current Health Wearable Monitoring System