QardioArm2 A200-IL

GUDID 10854894005354

QARDIO, INC.

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• Primary Device ID: 10854894005354
• NIH Device Record Key: fd31cf06-0f87-4131-a60b-e4d99d8f614a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QardioArm2
• Version Model Number: A200-IL
• Catalog Number: A200-IL
• Company DUNS: 080029958
• Company Name: QARDIO, 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: 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00854894005357 [Primary]
GS1	10854894005354 [Package]; Contains: 00854894005357; Package: MasterBox [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220106

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: 2023-06-27
• Device Publish Date: 2023-06-19

On-Brand Devices [QardioArm2]

• 10854894005354: A200-IL
• 10854894005347: A200