Agilis

GUDID 10840935108344

SUNTECH MEDICAL, INC.

Blood pressure ambulatory recorder

• Primary Device ID: 10840935108344
• NIH Device Record Key: 5d4b6223-2364-435d-b5af-f3226691c7f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Agilis
• Version Model Number: 97-0090-06
• 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: 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	10840935108344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010622

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: 2019-01-30

On-Brand Devices [Agilis]

• 10840935108368: 98-0037-01
• 10840935108351: 98-0036-01
• 10840935108344: 97-0090-06
• 10840935108337: 91-0058-01
• 10840935108320: 98-0032-06
• 10840935105466: 99-0013-60