WRISTECH

GUDID 14719872480102

Wrist type blood pressure monitor

HEALTH & LIFE CO., LTD.

Automatic-inflation electronic sphygmomanometer, non-portable

• Primary Device ID: 14719872480102
• NIH Device Record Key: f05b615d-5e04-4de9-a2cb-155e209d0697
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WRISTECH
• Version Model Number: JB5864
• Company DUNS: 657836743
• Company Name: HEALTH & LIFE CO., LTD.
• 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: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719872480105 [Primary]
GS1	14719872480102 [Package]; Contains: 04719872480105; Package: [24 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093824

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-10-12

On-Brand Devices [WRISTECH ]

• 14719872480188: wrist type blood pressure monitor
• 14719872480164: wrist type blood pressure monitor
• 14719872480102: Wrist type blood pressure monitor