Microport

GUDID 01084093510874

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 01084093510874
• NIH Device Record Key: 665ff368-f781-4d67-9dc6-520747038c56
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Microport
• Version Model Number: 99-0233-40
• Company DUNS: 148191133
• Company Name: SUNTECH MEDICAL, INC.
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	01084093510874 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151520

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: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-08-07

On-Brand Devices [Microport]

• 01084093510874: 99-0233-40
• 10840935108740: 99-0233-40