FORA

GUDID 00816042014826

P20 Blood Pressure Cuff, Small Size (7.5"- 9.8")

FORA CARE INC.

Blood pressure cuff, reusable

• Primary Device ID: 00816042014826
• NIH Device Record Key: 848a4997-6028-4b12-bdea-8084d8177a10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: Small Size
• Company DUNS: 004340807
• Company Name: FORA CARE 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: true
• Serial Number: false
• Manufacturing Date: true
• 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	00816042014826 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092106

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: 2023-03-29
• Device Publish Date: 2023-03-21

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• 00816042011276: Tympanic Thermometer (Bluetooth)
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• 00816042013553: Fingertip Pulse Oximeter
• 00816042013331: Multi-Functional Monitoring System
• 00816042013850: Multi-Functional Monitoring System
• 00816042013164: Ketone Test Strips