Analytic for Hemodynamic Instability

GUDID B823AHIP100

Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making

Fifth Eye, Inc.

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• Primary Device ID: B823AHIP100
• NIH Device Record Key: bd099ea1-fab5-4697-9677-9c8a3069869d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Analytic for Hemodynamic Instability
• Version Model Number: P1
• Company DUNS: 081336754
• Company Name: Fifth Eye, 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: 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
HIBCC	B823AHIP100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• deNovo: DEN200022

FDA Product Code

• QNV: Adjunctive Hemodynamic Indicator With Decision Point

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: 2021-05-18
• Device Publish Date: 2021-05-10

Devices Manufactured by Fifth Eye, Inc.

• B823AHIV200 - AHI System: 2022-02-21 The AHI System is an adjunctive monitoring method to enable identification of patients who are showing signs of hemodynamic inst
• B823AHIP100 - Analytic for Hemodynamic Instability: 2021-05-18Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making
• B823AHIP100 - Analytic for Hemodynamic Instability: 2021-05-18 Analytic for Hemodynamic Instability(AHI) provides adjunctive hemodynamic status information to support clinical decision-making