AMS PROOF

GUDID 00197644700561

HIGH BLOOD PRESSURE MONITOR

American Medical Solutions LLC

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• Primary Device ID: 00197644700561
• NIH Device Record Key: a9b93c3d-bf76-4f9a-b1fc-982d6086f0ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMS PROOF
• Version Model Number: JPD-HA101
• Company DUNS: 118331001
• Company Name: American Medical Solutions LLC
• 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: 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00197644700561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182495

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-19
• Device Publish Date: 2023-06-09