FORA

GUDID 00816042014871

Reusable NIBP Cuff (38-55cm)

FORA CARE INC.

Blood pressure cuff, reusable

• Primary Device ID: 00816042014871
• NIH Device Record Key: 98e6925e-fe74-417d-a427-fc1a0361bf10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FORA
• Version Model Number: XL
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816042014871 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152468

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: 2023-11-03
• Device Publish Date: 2023-10-26

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